Device product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
Z-2434-2023
Product summary
- Firm
- Datascope Corp.
- Event
- Event 92498
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 47 units (42 US, 5 OUS)
- Official record key
device-enforcement:Z-2434-2023
Official wording
Reason: Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
Code information: All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449, Model: 0998-UC-0800-75, UDI: N/A; Model: 0998-UC-0800-83, UDI: N/A; Model: 0998-UC-0800-85, UDI: N/A;
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Unknown
Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.