Recall Z-0337-2022 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
| Date | Dec 30, 2021 (initiated Nov 15, 2021) |
| Status | Open, Classified |
| Reason | Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability. |
| Root cause | Device Design |
| Action | On November 15, 2021, the firm issued an Urgent Medical Device Correction letter to all affected consignees which informed them that the exterior of the Cardiosave Hybrid and Rescue IABP may be susceptible to fluid ingress at specific locations on the device. IABPs contain various electronic circuit boards. Liquid spills, such as saline, can create bridges of resistance between the circuit components; causing the circuit to not function as intended. This can impact initiation or continuation of counterpulsation therapy. Datascope/Getinge had previously issued an Urgent Medical Device Correc |
| Quantity | 44 (US); 5 (OUS) |
| Distribution | Worldwide distribution - US Nationwide. |
| 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 |