medical Class III Updated 2021-05-05

Datascope Corp. recalls Cardiosave Rescue IABP - Product Usage: used to inflate and

Recalled Product

Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Hazard / Issue

There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Systems. UDI: 10607567112312 10607567108407 10607567113449
View official government recall

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