The Recall Desk

FDA (Devices) recall action 87482

Datascope Corp. recalled 2 products on 2021-05-05

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-05-05
Critical
0
Units
20,174

Why these products were recalled

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).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2021-05-05

    Datascope Cardiosave Rescue IABP Recalled for Cybersecurity Vulnerabilities

    Datascope Corp. is recalling Cardiosave Rescue IABP units due to cybersecurity vulnerabilities in a TCP/IP software library that may cause loss of communication to hospital systems.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-05-05

    Datascope Cardiosave Hybrid IABP Recalled for Cybersecurity Vulnerabilities

    Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to cybersecurity vulnerabilities in a TCP/IP software library that may cause loss of communication to hospital systems.

    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…
    Category
    Distribution
    0 states