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, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-00-0800-55

Class I - Dangerous

🏥 Medical Devices Recalled: February 7, 2023 Datascope Infusion Pumps Nationwide

What Should You Do?

Check if you have this product:
All serial numbers. Model 0998-00-0800-31, UDI-DI 10607567109053; Model 0998-00-0800-32, UDI-DI 10607567111117; Model 0998-00-0800-33, UDI-DI 10607567109008; Model 0998-00-0800-34, UDI-DI 10607567111940; Model 0998-00-0800-35, UDI-DI 10607567109107; Model 0998-00-0800-45, UDI-DI 10607567108421; Model 0998-00-0800-52, UDI-DI 10607567108438; Model 0998-00-0800-53, UDI-DI 10607567108391; Model 0998-00-0800-55, UDI-DI 10607567108414; Model 0998-00-0800-65, UDI-DI 10607567113432
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Datascope Corp.
Reason for Recall:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-00-0800-55

Product Codes/Lot Numbers:

All serial numbers. Model 0998-00-0800-31, UDI-DI 10607567109053; Model 0998-00-0800-32, UDI-DI 10607567111117; Model 0998-00-0800-33, UDI-DI 10607567109008; Model 0998-00-0800-34, UDI-DI 10607567111940; Model 0998-00-0800-35, UDI-DI 10607567109107; Model 0998-00-0800-45, UDI-DI 10607567108421; Model 0998-00-0800-52, UDI-DI 10607567108438; Model 0998-00-0800-53, UDI-DI 10607567108391; Model 0998-00-0800-55, UDI-DI 10607567108414; Model 0998-00-0800-65, UDI-DI 10607567113432