Datascope Corp.: 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).

Agency Publication Date: April 28, 2021

Affected Products

Product: Cardiosave Hybrid 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 0998-00-0800-32, 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

All Systems. UDI: 10607567111117 10607567109008 10607567111940 10607567109107 10607567108421 10607567108438 10607567108391 10607567108414 10607567113432

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

All Systems. UDI: 10607567112312 10607567108407 10607567113449

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87482

Status: Active

Manufacturer: Datascope Corp.

Manufactured In: United States

Units Affected: 2 products (10087 total)

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Sources: FDA iRES · Raw API Response

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