Recall Z-2615-2021 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 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
| Date | Sep 8, 2021 |
| Status | Open, Classified |
| Reason | The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions. |
| Root cause | Software design |
| Action | On Wednesday, September 8, 2021, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that all lots of Maquet Cardiosave Hybrid experience the following issue: Unexpected Shutdown Upon Battery Removal. Immediate Actions to be taken by Customers: To ensure that the Cardiosave Hybrid is not susceptible to shutdown during the removal of a battery, users should not eject a battery when: - There is a singulat battery in either battery charging bay and unused battery bay is empty. - The battery is charging on AC power (indicated by a flashin |
| Quantity | 3969 total (US), 3550 total (OUS) |
| Distribution | Nationwide domestic distribution. Foreign distribution worldwide. |
| 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 |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump Datascope Corp., Jul 2, 2015 |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case Datascope Corp., Jan 31, 2017 |