Device product
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
Z-0075-2022
Product summary
- Firm
- Datascope Corp.
- Event
- Event 88651
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5054 total (US), 5033 total (OUS)
- Official record key
device-enforcement:Z-0075-2022
Official wording
Reason: The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
Code information: All lots
Distribution pattern: Worldwide distribution - US Nationwide distribution.
Derived failure modes
-
Unknown
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.