🔍 RecallPedia

Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

Class I - Dangerous
🏥 Medical Devices Recalled: February 7, 2023 Datascope Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449 All serial numbers
  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:
An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.
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 Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

Product Codes/Lot Numbers:

Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449 All serial numbers

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1148-2023

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