Recall Z-1907-2023 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
| Date | Jun 14, 2023 (initiated May 4, 2023) |
| Status | Open, Classified |
| Reason | The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. |
| Root cause | Under Investigation by firm |
| Action | An URGENT FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION notification letter was sent to customer on 5/4/23. Actions to be taken by the customer: " Please locate the CARDIOSAVE Hybrid IABPs with the serial numbers listed in this notice. " Please ensure that all Cardiosave Hybrid Intra-Aortic Balloon Pump users at your facility are aware of this notice. " Please forward this information to all current and potential Cardiosave Hybrid IABPs users within your hospital / facility. " Please contact your local Getinge Service Representative to arrange to have the affected IFU USB drives replaced. " P |
| Quantity | 4 units |
| Distribution | International distribution in the country of Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112372 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP Cardiac Assist, Maquet Cardiovascular, LLC, Sep 15, 2011 |