🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: September 8, 2021 Datascope Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    All lots
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
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 Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Product Codes/Lot Numbers:

All lots

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0076-2022

Related Recalls

Battery Charging Station; Model: 0998-00-0802;

Datascope

Class I - Dangerous

The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.

Feb 6, 2026 Other Medical Devices Nationwide View Details →