Company: Datascope Corp.
Date of Enforcement Report: 5/5/2021
Class III
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
Recall Number: Z-1506-2021
REASON
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).
RECALLING FIRM/MANUFACTURER
Datascope Corp. on 3/22/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7192 total
DISTRIBUTION
U.S. Nationwide and International