The Recall Desk

FDA (Devices) recall action 92335

Datascope Corp. recalled 2 products on 2023-07-26

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
2023-07-26
Critical
0
Units
—

Why these products were recalled

An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.

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

1–2 of 2

  • SevereFDA (Devices)··2023-07-26

    Cardiosave Hybrid Intra-Aortic Balloon Pump recalls due to unexpected device shutdown

    Datascope has recalled Cardiosave Hybrid IABP models due to tantalum capacitor failures that may cause unexpected device shutdown, interrupting life-critical cardiac therapy.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 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 0998-UC-0800-31* 0998-UC-0800-33* 0998
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2023-07-26

    Cardiosave Rescue IABP Recalled Due to Unexpected Shutdown Risk

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to capacitor failures that may cause unexpected device shutdown. The devices may stop delivering therapy without warning.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
    Category
    Distribution
    0 states