CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product No. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85; UDI: 10607567112312, 10607567108407, 10607567113449; Lot No. ALL LOTS.
- 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:
- Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
- 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). Electromechanical system used to inflate and deflate intra-aortic balloons.
Product Codes/Lot Numbers:
Product No. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85; UDI: 10607567112312, 10607567108407, 10607567113449; Lot No. ALL LOTS.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3137-2024
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