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

September 08, 2021

Class II

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
reason.no_named_rule · v1.0.0

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.