Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.

Class I - Dangerous

🏥 Medical Devices Recalled: December 19, 2022 Datascope Infusion Pumps Nationwide

What Should You Do?

Check if you have this product:
All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-75, 10607567112312; 0998-00-0800-83, 10607567108407; 0998-00-0800-85, 10607567113449; 0998-UC-0800-75, 10607567112312; 0998-UC-0800-83, 10607567108407; 0998-UC-0800-85, 10607567113449.
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:: The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.

Product Codes/Lot Numbers:

All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-75, 10607567112312; 0998-00-0800-83, 10607567108407; 0998-00-0800-85, 10607567113449; 0998-UC-0800-75, 10607567112312; 0998-UC-0800-83, 10607567108407; 0998-UC-0800-85, 10607567113449.