Device product

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Z-2438-2023

July 31, 2023

Class I

Product summary

Firm: Datascope Corp.
Event: Event 92480
Status: Ongoing
Classification: Class I
Quantity: 9175 units
Official record key: device-enforcement:Z-2438-2023

Official wording

Reason: Users were identifying autofill failure conditions on the devices causing pump stops.

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

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Users were identifying autofill failure conditions on the devices causing pump stops.