The Recall Desk

FDA (Devices) recall action 91602

Datascope Corp. recalled 2 products on 2023-03-15

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
2023-03-15
Critical
0
Units
8,124

Why these products were recalled

An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.

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

  • SevereFDA (Devices)··2023-03-15

    Cardiosave Rescue Intra-Aortic Balloon Pumps recalled for connection failure

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to a coiled cord cable connection failure that may cause unexpected device shutdown and loss of communication.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2023-03-15

    Cardiosave Hybrid IABP Devices Recalled for Unexpected Shutdown Risk

    Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to a connection failure that may cause unexpected shutdown during use. The failure prevents communication between the device's display head and base unit.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, 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
    Category
    Distribution
    0 states