Device product
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
Z-1229-2023
Product summary
- Firm
- Datascope Corp.
- Event
- Event 91645
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8909 units
- Official record key
device-enforcement:Z-1229-2023
Official wording
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.
Code information: All Serial Numbers. Model Number: 0998-00-0800-31, UDI-DI:10607567109053; Model Number: 0998-00-0800-32, UDI-DI: 10607567111117; Model Number: 0998-00-0800-33, UDI-DI: 10607567109008; Model Number: 0998-00-0800-34, UDI-DI: 10607567111940; Model Number: 0998-00-0800-35, UDI-DI: 10607567109107; Model Number: 0998-00-0800-45, UDI-DI: 10607567108421; Model Number: 0998-00-0800-52, UDI-DI: 10607567108438; Model Number: 0998-00-0800-53, UDI-DI: 10607567108391; Model Number: 0998-00-0800-55, UDI-DI: 10607567108414; Model Number: 0998-00-0800-65, UDI-DI: 10607567113432
Distribution pattern: US Nationwide. Global Distribution.
Derived failure modes
-
Unknown
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.