🔍 RecallPedia

Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

Class I - Dangerous
🏥 Medical Devices Recalled: October 3, 2024 Medtronic Perfusion Systems Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
  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:
Medtronic Perfusion Systems
Reason for Recall:
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

Product Codes/Lot Numbers:

UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304

Distribution:

Distributed in: US, NY, OH, IL, NJ, MI, TN, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0289-2025

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