System, Balloon, Intra-Aortic And Control
FDA product code DSP · Class II (moderate risk) · 21 CFR 870.3535 · Cardiovascular
162510(k) clearances
0PMA approvals
193recalls
Manufacturers
- Datascope Corp. 64
- Kontron Instruments, Inc. 17
- Arrow Intl., Inc. 15
- Boston Scientific Corporation 14
- Aries Medical, Inc. 8
- Smec, Inc. 7
- Arrow International Inc 7
- Belmont Instrument Corp. 5
- C.R. Bard, Inc. 5
- Avco Medical Products 4
- Datascope Corp., Cardiac Assist Division 3
- Jedmed Instrument Co. 2
- Cardiac Assist, Maquet Cardiovascular, LLC 2
- Abiomed, Inc. 2
- Arrow International, Teleflex 1
- Yehuda Tamari 1
- Insightra Medical 1
- St Jude Medical 1
- Ppg Hellige B.V. 1
- Equilibrated Bio Systems, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250542 | AC3 Range Intra-Aortic Balloon PumpDSP · Special | Arrow International, LLC | 03/26/2025SE |
| K232343 | AC3 Series IABPDSP · Special | Arrow International, LLC | 08/30/2023SE |
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPDSP · Special | Arrow International, Inc. | 05/27/2020SE |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter KitDSP · Special | Arrow International, Inc. | 04/09/2020SE |
| K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP)DSP · Special | Arrow International, Teleflex | 11/12/2019SE |
| K190101 | UltraFlex IABDSP · Traditional | Arrow International, Inc. | 06/28/2019SE |
| K190117 | Fiberoptix IABDSP · Traditional | Arrow International, Inc. | 06/13/2019SE |
| K181122 | CARDIOSAVE Intra-Aortic Balloon PumpDSP · Special | Datascope Corp. | 05/31/2018SE |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDSP · Special | Datascope Corp. | 10/12/2017SE |
| K162820 | AC3 Series IABP SystemDSP · Traditional | Arrow International, Inc. | 03/31/2017SE |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…DSP · Special | Datascope Corp. | 01/31/2017SE |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDSP · Special | Datascope Corp. | 07/02/2015SE |
| K133074 | Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDSP · Special | Datascope Corp. | 12/12/2013SE |
| K122628 | Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDSP · Special | Datascope Corp., Cardiac Assist Division | 09/06/2012SE |
| K120868 | Mega(Tm) 7.5FR. 30CC Intra-Aortic Balloon Catheter and Accessories, Mega(Tm) 7.5FR. 40CC…DSP · Special | Datascope Corp., Cardiac Assist Division | 04/20/2012SE |
| K112372 | Cardiosave Hybrid Intra-Aortic Balloon PumpDSP · Special | Cardiac Assist, Maquet Cardiovascular, LLC | 09/15/2011SE |
| K112327 | Sensation(Tm) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesDSP · Special | Cardiac Assist, Maquet Cardiovascular, LLC | 09/09/2011SE |
| K091449 | Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…DSP · Special | Datascope Corp., Cardiac Assist Division | 06/18/2009SE |
| K082746 | Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20DSP · Traditional | Insightra Medical, Inc. | 01/12/2009SE |
| K070225 | Supracor Intr-Aortic Balloon Pump ConsoleDSP · Traditional | Abiomed, Inc. | 12/13/2007SE |
| K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…DSP · Special | Datascope Corp. | 01/05/2007SE |
| K062582 | Supracor Balloon CatheterDSP · Traditional | Abiomed, Inc. | 12/14/2006SE |
| K060309 | Autocat Intra-Aortic Balloon Pump SeriesDSP · Special | Arrow Intl., Inc. | 04/06/2006SE |
| K041281 | Datascope 7.5FR. Iab Catheter and AccessoriesDSP · Special | Datascope Corp. | 06/07/2004SE |
| K040801 | Intra-Aortic Balloon (Iab)DSP · Special | Arrow Intl., Inc. | 05/06/2004SE |
| K031636 | CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XXDSP · Abbreviated | Datascope Corp. | 08/11/2003SE |
| K031569 | Datascope Ca 40 8FR. Iabs, Model 0684-00-04XXDSP · Special | Datascope Corp. | 06/10/2003SE |
| K021462 | Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement…DSP · Special | Arrow Intl., Inc. | 06/06/2002SE |
| K020257 | Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's True…DSP · Traditional | Datascope Corp. | 04/24/2002SE |
| K013326 | Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…DSP · Special | Datascope Corp. | 11/02/2001SE |
| K002256 | Arrow Acat 2 Intra-Aortic Balloon PumpDSP · Traditional | Arrow Intl., Inc. | 05/03/2001SE |
| K010330 | Arrow Rediguard, 9FR. 50CC, Intra-Aortic Balloon Vatheter, IAB-R950-UDSP · Special | Arrow Intl., Inc. | 03/02/2001SE |
| K003598 | Datascope Profile 8FR. Alt B Iab, 34CC, Datascope Profile 8FR. Alt B Iab, 40CC, Model…DSP · Special | Datascope Corp. | 12/21/2000SE |
| K002949 | Modification to Datascope Profile 8FR. Iab, 34CC; Modification to Datascope Profile 8FR.…DSP · Special | Datascope Corp. | 10/20/2000SE |
| K000729 | Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC UniversalDSP · Special | Arrow Intl., Inc. | 05/19/2000SE |
| K994157 | Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…DSP · Traditional | Datascope Corp. | 03/13/2000SE |
| K993966 | 8FR. Narrowflex Universal Intra-Aortic Balloon CatheterDSP · Special | Arrow Intl., Inc. | 02/18/2000SE |
| K983866 | Belmont Model Ngpbp Intra-Aortic Balloon PumpDSP · Traditional | Belmont Instrument Corp. | 01/06/2000SE |
| K981660 | Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersDSP · Traditional | C.R. Bard, Inc. | 10/16/1998SE |
| K982538 | Belmont Portable Balloon Pump, Bard Transact IabpDSP · Special | Belmont Instrument Corp. | 10/02/1998SE |
| K970689 | IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-UDSP · Traditional | Arrow Intl., Inc. | 06/04/1998SE |
| K980850 | Bard 9FR., 40CC. Rediguard and Taperseal Intra-Aortic BalloonsDSP · Traditional | C.R. Bard, Inc. | 06/03/1998SE |
| K980780 | Datascope Percor Stat-Dl 9.5 Fr. 25, 34 and 40CC Intra-Aoric Balloons with Alternate B…DSP · Traditional | Datascope Corp. | 05/29/1998SE |
| K980385 | Datascope 8FR. Co-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…DSP · Traditional | Datascope Corp. | 05/01/1998SE |
| K973962 | Bard 9FR., 30CC Rediguard and Taperseal BalloonsDSP · Traditional | C.R. Bard, Inc. | 02/19/1998SE |
| K974247 | 40 CC GrandeDSP · Traditional | Boston Scientific Corp | 02/10/1998SE |
| K965209 | Acat 1 (Arrow Cardiac Assist Technology 1)DSP · Traditional | Arrow Intl., Inc. | 01/23/1998SE |
| K963865 | 8 Fr. -30CC Narrowflex Sheathless Intra-Aortic Balloon Catheter, Product Number IAB-04830SDSP · Traditional | Arrow Intl., Inc. | 09/16/1997SE |
| K972113 | 30 CC and 40 CC SUB-9 Nitinol and 30 and 40 CC SUB-9 Stainless SteelDSP · Traditional | Boston Scientific Corp | 09/02/1997SE |
| K971673 | 40 CC SumoDSP · Traditional | Boston Scientific Corp | 08/05/1997SE |
| K965236 | System 96 Intra-Aortic Balloon Pump (Iabp)DSP · Traditional | Datascope Corp. | 07/01/1997SE |
| K963920 | 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter,DSP · Traditional | Arrow Intl., Inc. | 06/17/1997SE |
| K964987 | Datascope Percor Stat - DL 9.5 Fr. 25 and 40CC Intra-Aortic Balloon for Optional…DSP · Traditional | Datascope Corp. | 03/17/1997SE |
| K963104 | 9.5 Fr.- Flexi-Cath Intra-Aortic and Control SystemDSP · Traditional | Arrow Intl., Inc. | 02/04/1997SE |
| K961509 | Intra-Aortic Balloon Pump System 97 ModifiedDSP · Traditional | Datascope Corp. | 11/15/1996SE |
| K963187 | Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930 - 940, 30…DSP · Traditional | Boston Scientific Corp | 11/04/1996SE |
| K962177 | Bard Taperseal Intra-Aortic Balloon Catheter & Introducer KitDSP · Traditional | C.R. Bard, Inc. | 09/04/1996SE |
| K961358 | Arrow Sheathless Intra-Aortic Balloon CatheterDSP · Traditional | Arrow Intl., Inc. | 07/02/1996SE |
| K960713 | 8 FR.-40CC Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number…DSP · Traditional | Arrow Intl., Inc. | 05/15/1996SE |
| K960166 | Percor Stat-Dl 9.5 Fr. 34 & 40CCDSP · Traditional | Datascope Corp. | 04/24/1996SE |
| K954431 | Percutaneous Intra-Aortic Balloon CathetersDSP · Traditional | Boston Scientific Corp | 01/11/1996SE |
| K952576 | Transport CartDSP · Traditional | Belmont Instrument Corp. | 12/26/1995SE |
| K952221 | Bsc/Ca 30 & 40 Sensation, Models 930 & 940DSP · Traditional | Boston Scientific Corp | 08/11/1995SE |
| K950687 | External Helium Supply (Accessory for Iabp)DSP · Traditional | Belmont Instrument Corp. | 05/24/1995SE |
| K945230 | Arrow Kink Resistant Flexi-Cath Intra-Aortic BalloonDSP · Traditional | Arrow Intl., Inc. | 05/09/1995SE |
| K940298 | Bsc/Ca Model 940 IabDSP · Traditional | Boston Scientific Corp | 04/06/1995SE |
| K943919 | 9.5 FR Sensation DL Intra-Aortic Ballon CatheterDSP · Traditional | Boston Scientific Corp | 03/23/1995SE |
| K942454 | Datascope 95 and 97 Iab Pump ConsoleDSP · Traditional | Datascope Corp. | 02/24/1995SE |
| K935184 | Redifurl and Teperseal DL Intra-Aortic Balloon Catheters with Hydromer CoatingDSP · Traditional | St. Jude Medical, Inc. | 02/10/1995SE |
| K944460 | Datascope Intra-Aortic Balloon with Modified Stat GardDSP · Traditional | Datascope Corp. | 12/09/1994SE |
| K936232 | Bsc/Ca Model 930 Iab, Bsc/Ca 30 SidewinderDSP · Traditional | Boston Scientific Corp | 10/14/1994SE |
| K940231 | Intra-Aortic Balloon for Optional Sheathless InsertionDSP · Traditional | Datascope Corp. | 09/13/1994SE |
| K940178 | Percor Stat-Dl 9.5 FR.34CC & 40CC /Percor Stat-Dl 10.5 FR.40CC & 50CC Intra-Aortic…DSP · Traditional | Datascope Corp. | 08/09/1994SE |
| K932268 | Modifications to Intra-Aortic BalloonsDSP · Traditional | Kontron Instruments, Inc. | 12/15/1993SE |
| K925248 | Modification of Intra-Aortic Balloon CathetersDSP · Traditional | Kontron Instruments, Inc. | 09/27/1993SE |
| K926000 | 9.5 FR Sidewinder DL Intra-Aortic Ballon CatheterDSP · Traditional | Boston Scientific Corp | 08/30/1993SE |
| K914802 | Datascope Percor Stat DL9.5 FR34CC Intra-Aort BallDSP · Traditional | Datascope Corp. | 08/25/1993SE |
| K911000 | Percor Stat DL 8.5 FR 40CC Intra-Aortic BalloonDSP · Traditional | Datascope Corp. | 08/25/1993SE |
| K920427 | Percor Stat DL 9.5 FR 40CC Intra-Aortic BalloonDSP · Traditional | Datascope Corp. | 08/03/1993SE |
| K905663 | Pediatric Intra-Aortic Balloon CathetersDSP · Traditional | Datascope Corp. | 08/02/1993SE |
| K922235 | System 97DSP · Traditional | Datascope Corp. | 04/27/1993SE |
| K924382 | Bard(R) Intra Aortic BalloonDSP · Traditional | C.R. Bard, Inc. | 04/07/1993SE |
| K921638 | System 90 Intra-Aortic Balloon Pump ConsoleDSP · Traditional | Datascope Corp. | 02/10/1993SE |
| K915580 | Belmont Model PBP Intra-Aortic Balloon PumpDSP · Traditional | Belmont Instrument Corp. | 10/30/1992SE |
| K913847 | System 90 and System 90TDSP · Traditional | Datascope Corp. | 03/11/1992SE |
| K912629 | Datascope System 95DSP · Traditional | Datascope Corp. | 03/11/1992SE |
| K910997 | Datascope Percor Stat Intra-Aortic BalloonDSP · Traditional | Datascope Corp. | 11/05/1991SI |
| K905313 | Kontron Intra-Aortic Balloon Pump, Model Kaat IIDSP · Traditional | Kontron Instruments, Inc. | 06/19/1991SE |
| K905056 | Percor Stat-Dl 9.5 FR W/Opt Insert W/O Intro SheatDSP · Traditional | Datascope Corp. | 06/11/1991SE |
| K903917 | Compact Monitor SMK 210,211,230,231,240DSP · Traditional | Ppg Hellige B.V. | 01/18/1991SE |
| K903344 | 9.5 FR Percutaneous DB Lumen 40CC Flexi-Cath (TM)DSP · Traditional | Kontron Instruments, Inc. | 01/15/1991SE |
| K903930 | Datascope Percor Stat DL 10.5 FR 50CCDSP · Traditional | Datascope Corp. | 11/16/1990SE |
| K904414 | Datascope Percor Stat DL 9.5 FR40CC Steril Eto GasDSP · Traditional | Datascope Corp. | 10/22/1990SE |
| K904018 | Datascope Percor Stat DL 9.5 FR 40CC Intra-Aor BalDSP · Traditional | Datascope Corp. | 10/19/1990SE |
| K903893 | Datascope Percor Stat 9.5 FR 40CC Intra-Aortic BalDSP · Traditional | Datascope Corp. | 10/19/1990SE |
| K903892 | Datascope Percor Stat 8.5 FR 40CC Intra-Aortic BalDSP · Traditional | Datascope Corp. | 10/19/1990SE |
| K903867 | Datascope Percor Stat DL 10.5 FR 40CCDSP · Traditional | Datascope Corp. | 10/19/1990SE |
| K903769 | Percor Stat DL 9.5 FR 34CC Intra-Aortic BalloonDSP · Traditional | Datascope Corp. | 10/19/1990SE |
| K903736 | Datascope Percor Stat DL10.5 FR40CC in Aortic BalDSP · Traditional | Datascope Corp. | 10/09/1990SE |
| K902057 | Percor Stat DL 8.5 FR 40CC Iab Only/Labeling ChangDSP · Traditional | Datascope Corp. | 09/25/1990SE |
| K892222 | 9.5F Percu Double Lumen Intra-Aortic BalloonDSP · Traditional | Kontron Instruments, Inc. | 09/14/1990SE |
| K896497 | Percor Stat-Dl 8.5 FR Intra-Aortic BalloonDSP · Traditional | Datascope Corp. | 08/17/1990SE |
| K900281 | Series 3001 IabpDSP · Traditional | Boston Scientific Corp | 04/19/1990SE |
| K895433 | Aries 30CC & 50CC Intra-Aortic Balloon & Cont. SysDSP · Traditional | Aries Medical, Inc. | 04/10/1990SE |
| K896920 | Sidewinder 40CC DL Intra-Aortic Balloon CatheterDSP · Traditional | Boston Scientific Corp | 03/06/1990SE |
| K896597 | The Sidewinder 40CC DL Intra-Aortic Balloon Cath.DSP · Traditional | Boston Scientific Corp | 02/12/1990SE |
| K896430 | Percor Stat-Dl 9.5 FR & Stat-Sl 8.5 FR Intra-AortiDSP · Traditional | Datascope Corp. | 02/05/1990SE |
| K894942 | Sidewinder 40CC DL Intra-Aortic Balloon CatheterDSP · Traditional | Boston Scientific Corp | 09/26/1989SE |
| K892799 | 8 FR Percutan Double Lumen Intra-Aortic BalloonDSP · Traditional | Kontron Instruments, Inc. | 09/20/1989SE |
| K892798 | 9 FR Percutan Double Lumen Intra-Aortic BalloonDSP · Traditional | Kontron Instruments, Inc. | 09/20/1989SE |
| K892797 | 10 FR Percutan Double Lumen Intra-Aortic BalloonDSP · Traditional | Kontron Instruments, Inc. | 09/20/1989SE |
| K892878 | Kontron Intra-Aortic Balloon Pump Model K9000DSP · Traditional | Kontron Instruments, Inc. | 09/13/1989SE |
| K893243 | Intra Aortic BalloonDSP · Traditional | Datascope Corp. | 06/20/1989SE |
| K882508 | 9.5 French Percutaneous Double Lumen BalloonDSP · Traditional | Kontron Instruments, Inc. | 03/20/1989SE |
| K882274 | 10.5 French Percutaneous Double Lumen Intra-AorticDSP · Traditional | Kontron Instruments, Inc. | 03/20/1989SE |
| K880289 | Datascope Percor Stat-Mil 9.5 FR Intra-Aortic BallDSP · Traditional | Datascope Corp. | 06/10/1988SE |
| K875036 | Intra-Aortic Balloon Pump Model KaatDSP · Traditional | Kontron Instruments, Inc. | 05/18/1988SE |
| K874816 | Kontron Intra-Aortic Balloon Pump Model K2000DSP · Traditional | Kontron Instruments, Inc. | 04/01/1988SE |
| K864994 | 40CC Per. Pre-Furl (S/L) Intra-Aortic CatheterDSP · Traditional | Aries Medical, Inc. | 06/19/1987SE |
| K864537 | 40CC Percutaneous Pre-Furl (D/L) Balloon CatheterDSP · Traditional | Aries Medical, Inc. | 06/19/1987SE |
| K864568 | 40CC Surgical Double Lumen Balloon CatheterDSP · Traditional | Aries Medical, Inc. | 05/12/1987SE |
| K864567 | 40CC Percutaneous Furl Dou. Lumen Balloon CatheterDSP · Traditional | Aries Medical, Inc. | 05/12/1987SE |
| K863185 | 40CC Percutaneous Furl Single Intra-Aortic BalloonDSP · Traditional | Aries Medical, Inc. | 01/16/1987SE |
| K863219 | System 90 TransportDSP · Traditional | Datascope Corp. | 01/14/1987SE |
| K860638 | Novemperc Double Lumen Intra-Aortic BalloonDSP · Traditional | Kontron Instruments, Inc. | 10/01/1986SE |
| K855102 | Monark 869 ErgometerDSP · Traditional | Equilibrated Bio Systems, Inc. | 05/09/1986SE |
| K860427 | Kontron Intra-Aortic Balloon Pump Model KaatDSP · Traditional | Kontron Instruments, Inc. | 05/07/1986SE |
| K853062 | Intra-Aortic Balloon Pump Model K2000DSP · Traditional | Kontron Instruments, Inc. | 01/22/1986SE |
| K840367 | Pressure Trigger Mod of Smec Intra-AortDSP · Traditional | Smec, Inc. | 12/11/1985SE |
| K850482 | Datascope 8.5 French Electrode Intra-Aortic BallooDSP · Traditional | Datascope Corp. | 08/22/1985SE |
| K844220 | Aries Medical Perflex Percutaneous 40CC D/L BallooDSP · Traditional | Aries Medical, Inc. | 02/20/1985SE |
| K833828 | Percor 9.5 FR Iab on Datascope CO2DSP · Traditional | Datascope Corp. | 02/08/1985SE |
| K831235 | Iabp #90 SystemDSP · Traditional | Datascope Corp. | 02/08/1985SE |
| K840037 | Modified Smec Percutaneous Intra-AorticDSP · Traditional | Smec, Inc. | 02/01/1985SE |
| K832753 | Percutaneous BalloonDSP · Traditional | Smec, Inc. | 10/13/1984SE |
| K833632 | Aries Medical Model 700DSP · Traditional | Aries Medical, Inc. | 05/16/1984SE |
| K831397 | French Intra-Aortic 9.5 Balloon on KonDSP · Traditional | Datascope Corp. | 11/02/1983SE |
| K831307 | Pecor 8.5 French Iab on a DatascopeDSP · Traditional | Datascope Corp. | 11/02/1983SE |
| K830411 | Miniscope MS-2DSP · Traditional | Jedmed Instrument Co. | 04/27/1983SE |
| K830410 | Ek Combi MSG-1DSP · Traditional | Jedmed Instrument Co. | 04/27/1983SE |
| K823739 | Intra-Aortic Balloon SystemDSP · Traditional | Smec, Inc. | 02/18/1983SE |
| K823342 | Percor Intra-Aortic Balloon InsertionDSP · Traditional | Datascope Corp. | 01/24/1983SE |
| K821951 | Datascope Model 83 Iabp SystemDSP · Traditional | Datascope Corp. | 12/21/1982SE |
| K823177 | Smec Balloon SystemDSP · Traditional | Smec, Inc. | 12/15/1982SE |
| K820882 | Pecor, Percor-Dl, 10.5 French W/SmecDSP · Traditional | Datascope Corp. | 10/18/1982SE |
| K821065 | Datascope 10.5 French Intra-Aortic BalDSP · Traditional | Datascope Corp. | 08/19/1982SE |
| K813355 | Modification of the Percutan-BalloonDSP · Traditional | Smec, Inc. | 07/02/1982SE |
| K820166 | Adaptation of Kantron 40 Cc. PdliabDSP · Traditional | Kontron Instruments, Inc. | 04/29/1982SE |
| K813182 | Datascope Modified #82 Iabp SystemDSP · Traditional | Datascope Corp. | 03/31/1982SE |
| K813023 | Fukuda Denshi Cardimax FK-11DSP · Traditional | Brentwood Instruments, Inc. | 12/02/1981SE |
| K811372 | Model 84 Transport SystemDSP · Traditional | Datascope Corp. | 08/03/1981SE |
| K810297 | Datascope Percor=Dl Dual-Lumen IntraDSP · Traditional | Datascope Corp. | 05/06/1981SE |
| K802924 | Kontron Percutaeous Double-LumenDSP · Traditional | Avco Medical Products | 03/11/1981SE |
| K802167 | Percor Datascope Intra-Aortic BalloonDSP · Traditional | Datascope Corp. | 01/13/1981SE |
| K801601 | Datascope/Avco ConnectorDSP · Traditional | Datascope Corp. | 01/13/1981SE |
| K790755 | Smec Balloon CannulaDSP · Traditional | Smec, Inc. | 05/14/1980SE |
| K790775 | Intra-Aortic Balloon, Type SDSP · Traditional | Datascope Corp. | 10/01/1979SE |
| K790241 | Intra-Aortic Balloon-PumpDSP · Traditional | Avco Medical Products | 02/23/1979SE |
| K781848 | Pump, Balloon Model 10DSP · Traditional | Avco Medical Products | 01/23/1979SE |
| K780280 | Balloon PumpDSP · Traditional | Datascope Corp. | 03/15/1978SE |
| K770821 | Pump, Balloon, Intra-Aortic, Tri-SegmentDSP · Traditional | Avco Medical Products | 05/06/1977SE |
| K760695 | Tamari-KaplittDSP · Traditional | Yehuda Tamari | 10/06/1976SE |
Recalls
| Recall | Product | Firm | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 11/04/2025Open, Classified |
| Z-0932-2026 Class III | Cardiosave RescueThe IFU addendum updates the Vibration and Shock Table to reference the correct standards. | Datascope Corp. | 10/23/2025Open, Classified |
| Z-0931-2026 Class III | Cardiosave HybridThe IFU addendum updates the Vibration and Shock Table to reference the correct standards. | Datascope Corp. | 10/23/2025Open, Classified |
| Z-2298-2025 Class II | Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog…Device contains indications for use and device compatibility claims that have not be reviewed and approved… | Insightra Medical Inc | 07/19/2025Terminated |
| 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. | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 08/08/2024Open, Classified |
| Z-1880-2024 Class I | Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF…Teleflex received reports indicating an infrequent condition that, when not identified and corrected… | ARROW INTERNATIONAL Inc. | 04/29/2024Open, Classified |
| Z-1879-2024 Class I | Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF…Teleflex received reports indicating an infrequent condition that, when not identified and corrected… | ARROW INTERNATIONAL Inc. | 04/29/2024Open, Classified |
| Z-1878-2024 Class I | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF…Teleflex received reports indicating an infrequent condition that, when not identified and corrected… | ARROW INTERNATIONAL Inc. | 04/29/2024Open, 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… | Datascope Corp. | 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… | Datascope Corp. | 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. | Datascope Corp. | 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. | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 07/31/2023Open, 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 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… | Datascope Corp. | 02/07/2023Open, Classified |