🔍 RecallPedia

LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.

Class I - Dangerous
🏥 Medical Devices Recalled: August 5, 2022 Datascope Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 10607567106571 Lot codes: 3000210759 3000210758 3000203002 3000198455 3000144227 3000142368 3000141069 3000140532 3000134522 3000130423 3000126591
  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 Corporation
Reason for Recall:
The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.

Product Codes/Lot Numbers:

UDI-DI: 10607567106571 Lot codes: 3000210759 3000210758 3000203002 3000198455 3000144227 3000142368 3000141069 3000140532 3000134522 3000130423 3000126591

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0131-2023

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