Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Class I - DangerousWhat Should You Do?
- Check if you have this product: All Serial Numbers. Model Number: 0998-00-0800-75, UDI-DI: 10607567112312; Model Number: 0998-00-0800-83, UDI-DI: 10607567108407; Model Number: 0998-00-0800-85, UDI-DI: 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:
- There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.
- 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, and 0998-00-0800-85
Product Codes/Lot Numbers:
All Serial Numbers. Model Number: 0998-00-0800-75, UDI-DI: 10607567112312; Model Number: 0998-00-0800-83, UDI-DI: 10607567108407; Model Number: 0998-00-0800-85, UDI-DI: 10607567113449
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1230-2023
Related Recalls
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