Recall Z-1229-2023 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, and 0998-00-0800-55
| Date | Mar 6, 2023 (initiated Feb 7, 2023) |
| Status | Open, Classified |
| Reason | There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir. |
| Root cause | Under Investigation by firm |
| Action | URGENT MEDICAL DEVICE CORRECTION dated 2/7/23 were sent to customers. There have been reported failures of the high pressure helium regulator which may cause a helium leak in the Cardiosave Hospital Cart. The high pressure helium regulator is located in the Cardiosave Hospital Cart and regulates the helium pressure of the external helium supply. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir. Please refer |
| Quantity | 8909 units |
| Distribution | US Nationwide. Global Distribution. |
| 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 |