Datascope Corp.
Medical device manufacturer in Mahwah, NJ.
136510(k) clearances
1PMA approvals
143recalls
Device types
- DSP System, Balloon, Intra-Aortic And Control 64
- DQX Wire, Guide, Catheter 10
- DRT Monitor, Cardiac (Incl. Cardiotachometer &… 7
- DYB Introducer, Catheter 5
- MHX Monitor, Physiological, Patient(With… 4
- DXN System, Measurement, Blood-Pressure… 4
- DSI Detector And Alarm, Arrhythmia 3
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 3
- MWI Monitor, Physiological, Patient (Without… 3
- CBQ Analyzer, Gas, Enflurane, Gaseous-Phase… 2
- DQA Oximeter 2
- DXG Computer, Diagnostic, Pre-Programmed… 2
- LDD Dc-Defibrillator, Low-Energy, (Including… 2
- DSF Recorder, Paper Chart 2
- LJS Catheter, Intravascular, Therapeutic… 1
- DQO Catheter, Intravascular, Diagnostic 1
- GDW Staple, Implantable 1
- DRR Amplifier And Signal Conditioner… 1
- DPT Probe, Blood-Flow, Extravascular 1
- CCL Analyzer, Gas, Oxygen, Gaseous-Phase 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K190884 | TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolGDW · Traditional | 12/26/2019SE |
| K181122 | CARDIOSAVE Intra-Aortic Balloon PumpDSP · Special | 05/31/2018SE |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDSP · Special | 10/12/2017SE |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…DSP · Special | 01/31/2017SE |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDSP · Special | 07/02/2015SE |
| K133074 | Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDSP · Special | 12/12/2013SE |
| K071805 | Netguard Automated Clinician Alert System, Model 0998-00-1600-XXDSI · Abbreviated | 09/25/2007SE |
| K062569 | Safeguard 24 CM Pressure Assisted DressingDXC · Abbreviated | 02/14/2007SE |
| K062098 | Spectrum Monitor, Model 0998-00-1000-XXXXXMHX · Abbreviated | 02/05/2007SE |
| K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…DSP · Special | 01/05/2007SE |
| K062754 | Gas Module Se, Model 0998-00-0481-02BZK · Traditional | 11/02/2006SE |
| K051897 | Trio MonitorMWI · Special | 08/12/2005SE |
| K042016 | Datascope Proguide Chronic Dialysis CatheterMSD · Traditional | 09/23/2004SE |
| K041907 | Trio MonitorMWI · Abbreviated | 07/23/2004SE |
| K041281 | Datascope 7.5FR. Iab Catheter and AccessoriesDSP · Special | 06/07/2004SE |
| K032338 | Trio Monitor Model 0998-00-0600MWI · Abbreviated | 02/11/2004SE |
| K031760 | Viewpoint Telemetry SystemMHX · Abbreviated | 10/10/2003SE |
| K031849 | Spectrum Patient Monitor, Model 0998-00-0500-XXXXXMHX · Abbreviated | 09/09/2003SE |
| K031636 | CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XXDSP · Abbreviated | 08/11/2003SE |
| K031569 | Datascope Ca 40 8FR. Iabs, Model 0684-00-04XXDSP · Special | 06/10/2003SE |
| K020550 | Passport 2 with View 12 ECG Analysis Module Model # 0998-00-0170-XXXXDSI · Traditional | 08/28/2002SE |
| K020257 | Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's True…DSP · Traditional | 04/24/2002SE |
| K011540 | Viewpoint Central Monitoring System, Model 0998-00-0187-07MHX · Abbreviated | 02/06/2002SE |
| K013326 | Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…DSP · Special | 11/02/2001SE |
| K003598 | Datascope Profile 8FR. Alt B Iab, 34CC, Datascope Profile 8FR. Alt B Iab, 40CC, Model…DSP · Special | 12/21/2000SE |
| K002949 | Modification to Datascope Profile 8FR. Iab, 34CC; Modification to Datascope Profile 8FR.…DSP · Special | 10/20/2000SE |
| K002365 | Datascope Reinforced Percutaneous Catheter Introducer SetDYB · Special | 08/25/2000SE |
| K001198 | Datascope Nitinol Catheter Guide Wire (145 CM), Datascope Nitinol Catheter Guide Wire…DQX · Special | 05/12/2000SE |
| K994157 | Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…DSP · Traditional | 03/13/2000SE |
| K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDSI · Abbreviated | 01/13/2000SE |
| K983575 | Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XXDXN · Traditional | 05/13/1999SE |
| K974178 | Passport 5L-CE Model 0998-00-0131XXXDRT · Traditional | 06/26/1998SE |
| K980780 | Datascope Percor Stat-Dl 9.5 Fr. 25, 34 and 40CC Intra-Aoric Balloons with Alternate B…DSP · Traditional | 05/29/1998SE |
| K980385 | Datascope 8FR. Co-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…DSP · Traditional | 05/01/1998SE |
| K974903 | Gas Module II, Model 0998-00-0143CBS · Traditional | 03/13/1998SE |
| K973007 | Datascope's 10 Fr. Flexisheath Percutaneous IntroducerDYB · Traditional | 11/06/1997SE |
| K970061 | Accutorr Plus Non Invasive Blood Pressure Monitor (0998-00-0117-XX)DQA · Traditional | 09/25/1997SE |
| K965236 | System 96 Intra-Aortic Balloon Pump (Iabp)DSP · Traditional | 07/01/1997SE |
| K964987 | Datascope Percor Stat - DL 9.5 Fr. 25 and 40CC Intra-Aortic Balloon for Optional…DSP · Traditional | 03/17/1997SE |
| K961509 | Intra-Aortic Balloon Pump System 97 ModifiedDSP · Traditional | 11/15/1996SE |
| K960166 | Percor Stat-Dl 9.5 Fr. 34 & 40CCDSP · Traditional | 04/24/1996SE |
| K943896 | Guide Wire for the Use with Datascope Percor Stat-Dl IabsDQX · Traditional | 12/22/1995SE |
| K942454 | Datascope 95 and 97 Iab Pump ConsoleDSP · Traditional | 02/24/1995SE |
| K944460 | Datascope Intra-Aortic Balloon with Modified Stat GardDSP · Traditional | 12/09/1994SE |
| K940231 | Intra-Aortic Balloon for Optional Sheathless InsertionDSP · Traditional | 09/13/1994SE |
| K940178 | Percor Stat-Dl 9.5 FR.34CC & 40CC /Percor Stat-Dl 10.5 FR.40CC & 50CC Intra-Aortic…DSP · Traditional | 08/09/1994SE |
| K926451 | Datascope Multinex IICBQ · Traditional | 08/25/1993SE |
| K914802 | Datascope Percor Stat DL9.5 FR34CC Intra-Aort BallDSP · Traditional | 08/25/1993SE |
| K911000 | Percor Stat DL 8.5 FR 40CC Intra-Aortic BalloonDSP · Traditional | 08/25/1993SE |
| K926099 | Datascope 6000 MonitorMLC · Traditional | 08/06/1993SE |
| K922103 | Iab AnchorKMK · Traditional | 08/03/1993SE |
| K920427 | Percor Stat DL 9.5 FR 40CC Intra-Aortic BalloonDSP · Traditional | 08/03/1993SE |
| K905663 | Pediatric Intra-Aortic Balloon CathetersDSP · Traditional | 08/02/1993SE |
| K930303 | Datascope Multinex Id PlusCBQ · Traditional | 06/16/1993SE |
| K922235 | System 97DSP · Traditional | 04/27/1993SE |
| K921638 | System 90 Intra-Aortic Balloon Pump ConsoleDSP · Traditional | 02/10/1993SE |
| K921526 | Datascope Passport Monitor with CO2CCK · Traditional | 10/14/1992SE |
| K913847 | System 90 and System 90TDSP · Traditional | 03/11/1992SE |
| K912629 | Datascope System 95DSP · Traditional | 03/11/1992SE |
| K910997 | Datascope Percor Stat Intra-Aortic BalloonDSP · Traditional | 11/05/1991SI |
| K911598 | Datascope Passport MonitorDRT · Traditional | 10/15/1991SE |
| K910116 | Turbo Support CatheterDQY · Traditional | 06/25/1991SE |
| K905056 | Percor Stat-Dl 9.5 FR W/Opt Insert W/O Intro SheatDSP · Traditional | 06/11/1991SE |
| K910106 | Datascope Multinex Id MonitorCCK · Traditional | 03/29/1991SE |
| K905432 | Datascope Interlock Guide Wire ExtensionDQX · Traditional | 01/30/1991SE |
| K902674 | Datascope Arterial Cannula W/Access PortDQR · Traditional | 01/16/1991SE |
| K904476 | Vessel DilatorDRE · Traditional | 12/10/1990SE |
| K904477 | GuidewireDQX · Traditional | 12/06/1990SE |
| K903930 | Datascope Percor Stat DL 10.5 FR 50CCDSP · Traditional | 11/16/1990SE |
| K904414 | Datascope Percor Stat DL 9.5 FR40CC Steril Eto GasDSP · Traditional | 10/22/1990SE |
| K904018 | Datascope Percor Stat DL 9.5 FR 40CC Intra-Aor BalDSP · Traditional | 10/19/1990SE |
| K903893 | Datascope Percor Stat 9.5 FR 40CC Intra-Aortic BalDSP · Traditional | 10/19/1990SE |
| K903892 | Datascope Percor Stat 8.5 FR 40CC Intra-Aortic BalDSP · Traditional | 10/19/1990SE |
| K903867 | Datascope Percor Stat DL 10.5 FR 40CCDSP · Traditional | 10/19/1990SE |
| K903769 | Percor Stat DL 9.5 FR 34CC Intra-Aortic BalloonDSP · Traditional | 10/19/1990SE |
| K902932 | Datascope Percor Percutaneous Introducer W/PeelablDYB · Traditional | 10/16/1990SE |
| K903736 | Datascope Percor Stat DL10.5 FR40CC in Aortic BalDSP · Traditional | 10/09/1990SE |
| K902057 | Percor Stat DL 8.5 FR 40CC Iab Only/Labeling ChangDSP · Traditional | 09/25/1990SE |
| K896497 | Percor Stat-Dl 8.5 FR Intra-Aortic BalloonDSP · Traditional | 08/17/1990SE |
| K901391 | Datascope Ptca Percutaneous Catheter IntroducerDYB · Traditional | 06/26/1990SE |
| K901347 | Datascope Slidewire(Tm)DQX · Traditional | 06/21/1990SE |
| K896430 | Percor Stat-Dl 9.5 FR & Stat-Sl 8.5 FR Intra-AortiDSP · Traditional | 02/05/1990SE |
| K894940 | Datascope Steering HandleDQX · Traditional | 11/01/1989SE |
| K894318 | Datascope Interlock Guide Wire ExtensionDQX · Traditional | 10/12/1989SE |
| K893243 | Intra Aortic BalloonDSP · Traditional | 06/20/1989SE |
| K890807 | Guide Wire IntroducerDQX · Traditional | 06/20/1989SE |
| K890800 | Rotating Hemostatic ValveLIT · Traditional | 06/12/1989SE |
| K883579 | Coronary Guide WireDQX · Traditional | 11/04/1988SE |
| K883254 | Multinex Monitor (Modification)CCL · Traditional | 09/12/1988SE |
| K880301 | 3000 Physiological MonitorDXG · Traditional | 08/19/1988SE |
| K880289 | Datascope Percor Stat-Mil 9.5 FR Intra-Aortic BallDSP · Traditional | 06/10/1988SE |
| K874138 | Accucom 2DPT · Traditional | 06/01/1988SE |
| K872024 | CO2/02 Monitor MultinexCCI · Traditional | 03/31/1988SE |
| K870664 | Guide WireDQX · Traditional | 03/25/1987SE |
| K863608 | Datascope Balloon Dilatation Catheter · Traditional | 02/10/1987SE |
| K863219 | System 90 TransportDSP · Traditional | 01/14/1987SE |
| K863855 | AccusatDQA · Traditional | 01/06/1987SE |
| K863308 | 2200I Physiological MonitorDXG · Traditional | 01/02/1987SE |
| K864167 | Percluder(Tm)-Dl Occluding Balloon(Heparin Coated) · Traditional | 11/06/1986SE |
| K860164 | 2500 Printer · Traditional | 06/05/1986SE |
| K850482 | Datascope 8.5 French Electrode Intra-Aortic BallooDSP · Traditional | 08/22/1985SE |
| K851904 | Data Trac Anesthesiology RecorderKZD · Traditional | 05/10/1985SE |
| K844353 | Physiological Monitor 2100DXN · Traditional | 04/01/1985SE |
| K842538 | Accutorr CSM SystemDXN · Traditional | 03/01/1985SE |
| K833828 | Percor 9.5 FR Iab on Datascope CO2DSP · Traditional | 02/08/1985SE |
| K831235 | Iabp #90 SystemDSP · Traditional | 02/08/1985SE |
| K844447 | M/D4 W/Charger (Cardiopac 3M11)LDD · Traditional | 01/14/1985SE |
| K841878 | Sheath RemoverLJS · Traditional | 07/13/1984SE |
| K831397 | French Intra-Aortic 9.5 Balloon on KonDSP · Traditional | 11/02/1983SE |
| K831307 | Pecor 8.5 French Iab on a DatascopeDSP · Traditional | 11/02/1983SE |
| K831776 | CapnographCCK · Traditional | 10/31/1983SE |
| K832386 | Percluder DL Occluding BalloonDQO · Traditional | 10/19/1983SE |
| K823342 | Percor Intra-Aortic Balloon InsertionDSP · Traditional | 01/24/1983SE |
| K821951 | Datascope Model 83 Iabp SystemDSP · Traditional | 12/21/1982SE |
| K820882 | Pecor, Percor-Dl, 10.5 French W/SmecDSP · Traditional | 10/18/1982SE |
| K821065 | Datascope 10.5 French Intra-Aortic BalDSP · Traditional | 08/19/1982SE |
| K820834 | Percor Percutaneous IntroducerDYB · Traditional | 04/14/1982SE |
| K813182 | Datascope Modified #82 Iabp SystemDSP · Traditional | 03/31/1982SE |
| K812828 | Model 2000 MonitorDRT · Traditional | 11/16/1981SE |
| K812259 | Nivp MonitorDXN · Traditional | 09/21/1981SE |
| K812271 | Central Station MonitorDRT · Traditional | 08/31/1981SE |
| K811372 | Model 84 Transport SystemDSP · Traditional | 08/03/1981SE |
| K811638 | Datascope Internal Defibrillator PaddlesLDD · Traditional | 07/10/1981SE |
| K810297 | Datascope Percor=Dl Dual-Lumen IntraDSP · Traditional | 05/06/1981SE |
| K802167 | Percor Datascope Intra-Aortic BalloonDSP · Traditional | 01/13/1981SE |
| K801601 | Datascope/Avco ConnectorDSP · Traditional | 01/13/1981SE |
| K790775 | Intra-Aortic Balloon, Type SDSP · Traditional | 10/01/1979SE |
| K781163 | Electrode, Deip.DRX · Traditional | 09/26/1978SE |
| K780280 | Balloon PumpDSP · Traditional | 03/15/1978SE |
| K780043 | Esis ModuleDRR · Traditional | 02/13/1978SE |
| K772056 | Physiological Monitor Model 871DRT · Traditional | 11/22/1977SE |
| K772054 | Physiological Recorder Model 740DSF · Traditional | 11/22/1977SE |
| K772052 | Physiological Recorder Model 721ADSF · Traditional | 11/22/1977SE |
| K772053 | Line Charger Model LC-100DRT · Traditional | 11/09/1977SE |
| K761017 | Pressure Module (Model P3)DRQ · Traditional | 11/15/1976SE |
| K760803 | Physiological Monitor (Model 870)DRT · Traditional | 10/20/1976SE |
PMA approvals
- P850023 Hemopad Absorbable Collagen Hemostat · 05/27/1986 · 12 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1587-2026 Class III | Battery Charging Station; Model: 0998-00-0802;The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion… | 02/06/2026Open, Classified |
| Z-1487-2026 Class II | CS300 IABP. Software Version CS300 IABP C.01.The firm has identified that the battery runtime and cycle specifications contained in the devices… | 01/23/2026Open, Classified |
| Z-1486-2026 Class II | CS100 IABP. Software Version CS100 IABP Q.01.The firm has identified that the battery runtime and cycle specifications contained in the devices… | 01/23/2026Open, Classified |
| Z-0917-2026 Class II | Cardiosave Rescue. Intra-Aortic Balloon Pump system.The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the… | 11/04/2025Open, Classified |
| Z-0916-2026 Class II | Cardiosave Hybrid. Intra-Aortic Balloon Pump system.The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the… | 11/04/2025Open, Classified |
| Z-0932-2026 Class III | Cardiosave RescueThe IFU addendum updates the Vibration and Shock Table to reference the correct standards. | 10/23/2025Open, Classified |
| Z-0931-2026 Class III | Cardiosave HybridThe IFU addendum updates the Vibration and Shock Table to reference the correct standards. | 10/23/2025Open, Classified |
| Z-0311-2025 Class II | MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01There is discrepant labeling on the inner and outer packaging of the device. | 09/17/2024Open, Classified |
| Z-3137-2024 Class I | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to…Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems… | 08/08/2024Open, Classified |
| Z-3136-2024 Class I | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to…Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems… | 08/08/2024Open, Classified |
| Z-3135-2024 Class I | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to…Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that… | 08/08/2024Open, Classified |
| Z-3134-2024 Class I | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to…Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that… | 08/08/2024Open, Classified |
| Z-2487-2023 Class II | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75…Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the… | 07/31/2023Open, Classified |
| Z-2486-2023 Class II | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31…Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the… | 07/31/2023Open, Classified |
| Z-2438-2023 Class I | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75…Users were identifying autofill failure conditions on the devices causing pump stops. | 07/31/2023Open, Classified |
| Z-2437-2023 Class I | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31…Users were identifying autofill failure conditions on the devices causing pump stops. | 07/31/2023Open, Classified |
| Z-2436-2023 Class I | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75…Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while… | 07/31/2023Open, Classified |
| Z-2435-2023 Class I | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31…Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while… | 07/31/2023Open, Classified |
| Z-2434-2023 Class I | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75…Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave… | 07/31/2023Open, Classified |
| Z-2433-2023 Class I | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31…Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave… | 07/31/2023Open, Classified |
| Z-2432-2023 Class I | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75…Users were reporting that the device was not charging as expected. It was discovered that users were unaware… | 07/31/2023Open, Classified |
| Z-2431-2023 Class I | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31…Users were reporting that the device was not charging as expected. It was discovered that users were unaware… | 07/31/2023Open, Classified |
| Z-2224-2023 Class II | REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2223-2023 Class II | LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2222-2023 Class II | SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2221-2023 Class II | SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2220-2023 Class II | MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2219-2023 Class II | MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2218-2023 Class II | TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2217-2023 Class II | SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2216-2023 Class II | YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter…During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the… | 06/23/2023Open, Classified |
| Z-2152-2023 Class I | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75…An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management… | 06/05/2023Open, Classified |
| Z-2151-2023 Class I | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31…An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management… | 06/05/2023Open, Classified |
| Z-2150-2023 Class I | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75…IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if… | 06/05/2023Open, Classified |
| Z-2149-2023 Class I | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31…IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if… | 06/05/2023Open, Classified |
| Z-1907-2023 Class III | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part…The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly… | 05/04/2023Open, Classified |
| Z-1462-2023 Class II | MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the… | 04/04/2023Open, Classified |
| Z-1279-2023 Class II | Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model…There is an issue related to the Safety Disk not meeting a performance requirement that may impact… | 02/28/2023Open, Classified |
| Z-1278-2023 Class II | Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140There is an issue related to the Safety Disk not meeting a performance requirement that may impact… | 02/28/2023Open, Classified |
| Z-1277-2023 Class II | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers…There is an issue related to the Safety Disk not meeting a performance requirement that may impact… | 02/28/2023Open, Classified |
| Z-1276-2023 Class II | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31…There is an issue related to the Safety Disk not meeting a performance requirement that may impact… | 02/28/2023Open, Classified |
| Z-1232-2023 Class II | Cardiosave Rescue. Model Number: 0998-00-0800-83.Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect… | 02/07/2023Open, Classified |
| Z-1231-2023 Class II | Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31…Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect… | 02/07/2023Open, Classified |
| Z-1230-2023 Class II | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75…There have been reported failures of the high pressure helium regulator, which may cause a helium leak in… | 02/07/2023Open, Classified |
| Z-1229-2023 Class II | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31…There have been reported failures of the high pressure helium regulator, which may cause a helium leak in… | 02/07/2023Open, Classified |
| Z-1148-2023 Class I | Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor… | 02/07/2023Open, Classified |
| Z-1147-2023 Class I | Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33…An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor… | 02/07/2023Open, Classified |
| Z-1146-2023 Class I | Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part…An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord… | 02/07/2023Open, Classified |
| Z-1145-2023 Class I | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part…An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord… | 02/07/2023Open, Classified |
| Z-0886-2023 Class I | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75…The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is… | 12/19/2022Open, Classified |
| Z-0885-2023 Class I | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31…The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is… | 12/19/2022Open, Classified |
| Z-1687-2022 Class II | Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon CatheterCertain lots containing undersized dilator. | 08/05/2022Open, Classified |
| Z-1686-2022 Class II | Sensation Plus 8Fr 50cc Intra-Aortic Balloon CatheterCertain lots containing undersized dilator. | 08/05/2022Open, Classified |
| Z-1685-2022 Class II | MEGA 8Fr 50cc Intra-Aortic Balloon CatheterCertain lots containing undersized dilator. | 08/05/2022Open, Classified |
| Z-0131-2023 Class II | LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic…The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels… | 08/05/2022Open, Classified |
| Z-0337-2022 Class I | Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75…Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short… | 11/15/2021Open, Classified |
| Z-0336-2022 Class I | Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31…Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short… | 11/15/2021Open, Classified |
| Z-0091-2022 Class I | Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave…A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime… | 09/21/2021Open, Classified |
| Z-2616-2021 Class II | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75…The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is… | 09/08/2021Open, Classified |
| Z-2615-2021 Class II | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31…The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is… | 09/08/2021Open, Classified |
| Z-0076-2022 Class II | Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75…The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the… | 09/08/2021Open, Classified |
| Z-0075-2022 Class II | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31…The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the… | 09/08/2021Open, Classified |
| Z-1507-2021 Class III | Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic…There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result… | 03/22/2021Open, Classified |
| Z-1506-2021 Class III | Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic…There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result… | 03/22/2021Open, Classified |
| Z-2847-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2846-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2845-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2844-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2843-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2842-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2841-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2840-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2839-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2838-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2837-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2836-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2835-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2834-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2833-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2832-2020 Class II | Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-2831-2020 Class II | Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N:…Potential Endotoxin Contamination | 07/27/2020Open, Classified |
| Z-0934-2020 Class II | Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory…Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets… | 11/20/2019Terminated |
| Z-0933-2020 Class II | Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory…Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets… | 11/20/2019Terminated |
| Z-0932-2020 Class II | Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an…Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets… | 11/20/2019Terminated |
| Z-0266-2020 Class II | Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300…One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an… | 10/03/2019Terminated |
| Z-1944-2019 Class I | CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.If battery maintenance is not performed per instructions, the battery may provide less than the minimum run… | 06/17/2019Open, Classified |
| Z-1943-2019 Class I | CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.If battery maintenance is not performed per instructions, the battery may provide less than the minimum run… | 06/17/2019Open, Classified |
| Z-1942-2019 Class I | CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.If battery maintenance is not performed appropriately, the battery may provide less than the minimum run… | 06/17/2019Open, Classified |
| Z-1941-2019 Class I | CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.If battery maintenance is not performed appropriately, the battery may provide less than the minimum run… | 06/17/2019Open, Classified |
| Z-1940-2019 Class I | Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.If battery maintenance is not performed appropriately, the battery may provide less than the minimum run… | 06/17/2019Open, Classified |
| Z-1939-2019 Class I | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular…Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and… | 06/17/2019Open, Classified |
| Z-1966-2019 Class II | Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number…The device was distributed with the outer carton labeled with the manufacture date and the expiry date… | 05/28/2019Terminated |
| Z-1385-2018 Class II | Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon…The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the… | 02/21/2018Terminated |
| Z-1384-2018 Class II | Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon…The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the… | 02/21/2018Terminated |
| Z-1383-2018 Class II | Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon…The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the… | 02/21/2018Terminated |
| Z-1733-2018 Class II | BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1732-2018 Class II | BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1731-2018 Class II | BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1730-2018 Class II | BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1729-2018 Class II | BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1728-2018 Class II | BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1727-2018 Class II | ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1726-2018 Class II | BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1725-2018 Class II | NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1724-2018 Class II | BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1723-2018 Class II | BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1722-2018 Class II | BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1721-2018 Class II | BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1720-2018 Class II | BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1719-2018 Class II | BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1718-2018 Class II | BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1717-2018 Class II | BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1716-2018 Class II | BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No.…The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1715-2018 Class II | BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1714-2018 Class II | BEQ-TOP 22701, Catalog No. 701050790The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1713-2018 Class II | BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1712-2018 Class II | BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1711-2018 Class II | BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1710-2018 Class II | BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1709-2018 Class II | BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1708-2018 Class II | Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1707-2018 Class II | Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-1706-2018 Class II | BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer.… | 10/19/2017Terminated |
| Z-2180-2018 Class II | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number…There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. | 07/27/2017Terminated |
| Z-2179-2018 Class II | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part…There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. | 07/27/2017Terminated |
| Z-2178-2018 Class II | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number…There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through. | 07/27/2017Terminated |
| Z-2164-2017 Class II | SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK…Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr.… | 04/12/2017Terminated |
| Z-1769-2017 Class II | Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058…A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to… | 02/16/2017Terminated |
| Z-1935-2016 Class II | MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr.…It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath… | 05/13/2016Terminated |
| Z-2002-2016 Class II | Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with…Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin… | 05/09/2016Terminated |
| Z-2106-2018 Class III | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number…There is a potential problem with the cuvette where failure of the cuvette would cause an error message on… | 03/11/2016Terminated |
| Z-2105-2018 Class III | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part…There is a potential problem with the cuvette where failure of the cuvette would cause an error message on… | 03/11/2016Terminated |
| Z-2104-2018 Class III | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588There is a potential problem with the cuvette where failure of the cuvette would cause an error message on… | 03/11/2016Terminated |
| Z-2568-2014 Class III | LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge GroupDuring label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR… | 08/11/2014Terminated |
| Z-1813-2010 | System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and…Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related… | 05/10/2010Terminated |
| Z-1812-2010 | CS300 Intra-Aortic Balloon PumpCertain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related… | 05/10/2010Terminated |
| Z-1811-2010 | CS100 Intra-Aortic Balloon Pump.Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related… | 05/10/2010Terminated |
| Z-1198-2009 | Low-Level Output Cable. The device is used to allow the information displayed on the…Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump… | 02/04/2009Terminated |
| Z-0567-2008 | Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon…Defective Circuit Board -- A defect in the Printed Circuit Board's (PCB) in the CS 100 and CS300… | 11/19/2007Terminated |
| Z-0150-2008 | Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions…Display problems: If an ECG cable, which has been damaged due to the ingress of liquid or by mechanical… | 10/09/2007Terminated |
| Z-1158-2007 | Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar Device.…Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device.… | 05/07/2007Terminated |
| Z-1157-2007 | The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar…Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device.… | 05/07/2007Terminated |
| Z-1156-2007 | Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The…Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device.… | 05/07/2007Terminated |