Control, Pump Speed, Cardiopulmonary Bypass
FDA product code DWA · Class II (moderate risk) · 21 CFR 870.4380 · Cardiovascular
37510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Medtronic Bio-Medicus, Inc. 6
- Levitronix, LLC 6
- Bio Medicus, Inc. 3
- Stockert Instrumente GmbH 3
- Sorin Group Deutschland GmbH 3
- Apmtd, Inc. 2
- Medtronic Perfusion Systems 2
- Medtronic, Inc. 2
- Cardiacassist, Inc. 1
- Inspira Technologies Oxy B.H.N. , Ltd. 1
- Spectrum Medical , Ltd. 1
- Abbott (Formerly Thoratec Corporation) 1
- Thoratec Corporation (Now Part of Abbott) 1
- Thoratec Corp. 1
- Medtronic Vascular 1
- C.R. Bard, Inc. 1
- 3M Health Care, Sarns 1
- Gambro, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232788 | Inspira ART100DWA · Traditional | Inspira Technologies Oxy B.H.N. , Ltd. | 05/24/2024SE |
| K230698 | Anivia SG1000 Pump ConsoleDWA · Special | Apmtd, Inc. | 04/18/2023SE |
| K221491 | Anivia SG1000 Pump ConsoleDWA · Traditional | Apmtd, Inc. | 02/03/2023SE |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureDWA · Traditional | Spectrum Medical , Ltd. | 04/13/2020SE |
| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…DWA · Special | Abbott (Formerly Thoratec Corporation) | 03/06/2020SE |
| K191557 | CentriMag Acute Circulatory Support SystemDWA · Special | Thoratec Corporation (Now Part of Abbott) | 07/10/2019SE |
| K131964 | Bio-Console 560 Extracorporeal Blood Pumping ConsoleDWA · Special | Medtronic, Inc. | 07/24/2013SE |
| K131179 | Centrimag Primary Console (2ND Generation); Mag MonitorDWA · Special | Thoratec Corp | 07/18/2013SE |
| K112225 | Sorin Centrifugal Pump 5 (CP5)DWA · Special | Sorin Group Deutschland GmbH | 09/20/2011SE |
| K103468 | Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)DWA · Traditional | Sorin Group Deutschland GmbH | 01/20/2011SE |
| K102129 | Levitronix 2ND Generation Centrimag Primary Console, Levitronix MonitorDWA · Special | Levitronix, LLC | 08/27/2010SE |
| K093832 | Levitronix Centrimag Primary and Backup ConsolesDWA · Special | Levitronix, LLC | 01/13/2010SE |
| K091008 | Stockert Centrifugal Pump Plus System (SCP Plus), Models 60-00-10, 60-00-55DWA · Special | Sorin Group Deutschland GmbH | 07/15/2009SE |
| K090004 | Levitronix, Thoratec Centrimag Back-Up ConsolesDWA · Special | Levitronix, LLC | 01/15/2009SE |
| K083340 | Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary ConsoleDWA · Special | Levitronix, LLC | 11/26/2008SE |
| K081221 | Levitronix Centrimag Primary Console, Thoratec Centrimag Primary ConsoleDWA · Traditional | Levitronix, LLC | 06/19/2008SE |
| K080824 | Bio-Console 560DWA · Traditional | Medtronic Perfusion Systems | 05/07/2008SE |
| K070286 | Bio-Console, Model 560DWA · Traditional | Medtronic | 05/22/2007SE |
| K061369 | Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500DWA · Special | Cardiacassist, Inc. | 08/22/2006SE |
| K053630 | Levitronix Centrimag Primary ConsoleDWA · Special | Levitronix, LLC | 01/26/2006SE |
| K051303 | Bio-Console, Model 560DWA · Special | Medtronic Perfusion Systems | 06/10/2005SE |
| K042374 | Stockert SCP RhythmDWA · Special | Stockert Instrumente GmbH | 09/23/2004SE |
| K032213 | Stockert Centrifugal Pump System with Tubing ClampDWA · Traditional | Stockert Instrumente GmbH | 08/29/2003SE |
| K011838 | Centrifugal PumpDWA · Traditional | Stockert Instrumente GmbH | 02/05/2002SE |
| K971421 | Bard Isoflow Blood PumpDWA · Traditional | C.R. Bard, Inc. | 05/14/1998SE |
| K950739 | 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion SystemDWA · Traditional | 3M Health Care, Sarns | 11/17/1995SE |
| K936091 | Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed ControllerDWA · Traditional | Medtronic Bio-Medicus, Inc. | 12/23/1994SE |
| K941921 | Bio-Medicus Bio-Console Models 540, 540A,B,C,D,E, & 550DWA · Traditional | Medtronic Bio-Medicus, Inc. | 07/20/1994SE |
| K926357 | Medtronic Bio-Medicus Handcrank Model 150DWA · Traditional | Medtronic Bio-Medicus, Inc. | 06/02/1993SE |
| K924206 | Medtronic Bio-Medicus Bio-Console Model 540EDWA · Traditional | Medtronic Bio-Medicus, Inc. | 05/07/1993SE |
| K924205 | Medtronic Bio-Medicus Bio-Console Model 550DWA · Traditional | Medtronic Bio-Medicus, Inc. | 05/06/1993SE |
| K914754 | Medtronic Bio-Medicus Bio-Console Model 540-DDWA · Traditional | Medtronic Bio-Medicus, Inc. | 05/20/1992SE |
| K901584 | Bio-Medicus Bio Console Models 540 a B CDWA · Traditional | Bio Medicus, Inc. | 06/28/1990SE |
| K854133 | Bio Medicus Bio Console 540DWA · Traditional | Bio Medicus, Inc. | 01/08/1986SE |
| K853126 | Bio Pack Model 200DWA · Traditional | Bio Medicus, Inc. | 10/11/1985SE |
| K842503 | Gambro Pulsatile Monitor PLM 10-200DWA · Traditional | Gambro, Inc. | 08/10/1984SE |
| K780952 | Model 1812 Control Console, AccessoriexDWA · Traditional | Medtronic Vascular | 08/31/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0926-2023 Class I | SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC…A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on… | Cardiac Assist, Inc | 12/05/2022Terminated |
| Z-1763-2022 Class I | TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000…Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not… | Cardiac Assist, Inc | 07/21/2022Terminated |
| Z-0787-2022 Class III | Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI:…One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. | LivaNova Deutschland GmbH | 12/17/2021Terminated |
| Z-1313-2021 Class I | Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC…An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit… | Medtronic Perfusion Systems | 03/03/2021Open, Classified |
| Z-2440-2020 Class II | Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2…The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a… | LivaNova Deutschland GmbH | 08/26/2019Terminated |
| Z-2439-2020 Class II | Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2…The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a… | LivaNova Deutschland GmbH | 08/26/2019Terminated |
| Z-0401-2018 Class II | CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump…Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection… | Sorin Group Deutschland GmbH | 10/30/2017Terminated |
| Z-0857-2014 Class II | CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended…Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to… | Sorin Group Deutschland GmbH | 12/04/2013Terminated |
| Z-0167-2013 Class II | SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131…Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the… | Sorin Group USA, Inc. | 09/20/2012Terminated |
| Z-0166-2013 Class II | SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121…Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the… | Sorin Group USA, Inc. | 09/20/2012Terminated |
| Z-1329-2012 | Pump control panel. The S5 Perfusion System is used to perform, control and monitor…The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed.… | Sorin Group Deutschland GmbH | 02/23/2012Terminated |
| Z-1939-2010 | Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord…The potential risks during the use of this power cord include electrical shock, delay in setup and therapy… | Medtronic Cardiovascular Revascularization… | 04/21/2010Terminated |