Product Safety Recalls

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Datascope Corp. Recall 87482

Description: 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

Datascope Corp. Recall 87482 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1507-2021
Event ID87482
Event DescriptionCardiosave 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
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution.
Quantity7192 total
Recall ReasonThere 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).
Device Classification20210505
Device Code InfoAll Systems. UDI: 10607567112312 10607567108407 10607567113449
Center Classification Date20210428
Recall Initiation Date20210322
Recalling FirmDatascope Corp.
Initial Notification Letter
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