Recall Z-1462-2023 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
| Date | Apr 26, 2023 (initiated Apr 4, 2023) |
| Status | Open, Classified |
| Reason | The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle. |
| Root cause | Component design/selection |
| Action | An URGENT FIELD SAFETY NOTICE MEDICAL DEVICE CORRECTION was sent to customers beginning 4/4/23. Actions to be taken by the Customer now: Our records indicate that that you have received one or more CARDIOSAVE hybrid IABPs having the serial numbers that are affected by this recall. 1. Inspect the IABP to determine if it has a Type J power plug (refer to Image 1 below). If present, the IABP should not be used until the cord reel has been replaced. 2. Schedule a service appointment with your Datascope Corp./Getinge Service Representative for the cord reel correction from a Type J connect |
| Quantity | 54 units |
| Distribution | International distribution in the country of Brazil. |
| 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 |