Device product
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.
Z-0337-2022
Product summary
- Firm
- Datascope Corp.
- Event
- Event 88983
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 44 (US); 5 (OUS)
- Official record key
device-enforcement:Z-0337-2022
Official wording
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.
Code information: All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-75, 10607567112312; 0998-UC-0800-75, 10607567112312; 0998-00-0800-83, 10607567108407; 0998-UC-0800-83, 10607567108407; 0998-00-0800-85, 10607567113449; 0998-UC-0800-85, 10607567113449.
Distribution pattern: Worldwide distribution - US Nationwide.
Derived failure modes
-
Unknown
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.