Home › Device types › DWA
Control, Pump Speed, Cardiopulmonary Bypass
FDA product code DWA · Class 2 · Cardiovascular
111
Registered devices
3,469
Adverse events
12
Recalls
37
510(k) clearances
Devices with this code
Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationCENTRIMAG® BACK-UP CONSOLE WITH BATTERIES — Thoratec Switzerland GmbHNA — MEDTRONIC, INC.INSPIRA ART100 — INSPIRA TECHNOLOGIES OXY B.H.N LTDNA — MEDTRONIC, INC.NA — MEDTRONIC, INC.INSPIRA ART100 — INSPIRA TECHNOLOGIES OXY B.H.N LTDSarns™ Centrifugal System — Terumo Cardiovascular Systems CorporationMONITOR ARM CLAMP — Thoratec Switzerland GmbHNA — MEDTRONIC, INC.Anivia SG1000 Pump Console — APMTD, Inc.LifeSPARC — CARDIACASSIST, INC.LifeSPARC — CARDIACASSIST, INC.NA — MEDTRONIC, INC.Anivia SG1000 Pump Console — APMTD, Inc.Bio-Console® — MEDTRONIC, INC.NA — MEDTRONIC, INC.CENTRIMAG® Back-Up Console with Batteries — Thoratec Switzerland GmbHINSPIRA ART100 — INSPIRA TECHNOLOGIES OXY B.H.N LTDNA — MEDTRONIC, INC.NA — MEDTRONIC, INC.Anivia SG1000 Pump Console — APMTD, Inc.INTERNAL RECHARGEABLE NIMH BATTERY PACK FOR CENTRIMAG PRIMARY CONSOLE — Thoratec Switzerland GmbHLifeSPARC — CARDIACASSIST, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-05 | Cardiac Assist, Inc | A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was fir |
| 2022-07-21 | Cardiac Assist, Inc | Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. |
| 2021-12-17 | LivaNova Deutschland GmbH | One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. |
| 2021-03-03 | Medtronic Perfusion Systems | An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping |
| 2019-08-26 | LivaNova Deutschland GmbH | The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be dif |
| 2019-08-26 | LivaNova Deutschland GmbH | The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be dif |
| 2017-10-30 | Sorin Group Deutschland GmbH | Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bubble could take longer than is intended |
| 2013-12-04 | Sorin Group Deutschland GmbH | Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting |
| 2012-09-20 | Sorin Group USA, Inc. | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An |
| 2012-09-20 | Sorin Group USA, Inc. | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An |
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