🔍 RecallPedia

Thin-Flex Venous Cannula, Model Number:TF292902A

Class I - Dangerous
🏥 Medical Devices Recalled: November 4, 2015 Edwards Lifesciences Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot No: 59384061 59677936 59985533 59430941 59723695 59999044 59456603 59746454 60010418 59498228 59779239 60106398 59545464 59846864 60113045 59580433 59883622 60121142 59608030 59931290 60172116 59649580 59963196 60181079
  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:
Edwards Lifesciences, LLC
Reason for Recall:
Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Thin-Flex Venous Cannula, Model Number:TF292902A

Product Codes/Lot Numbers:

Lot No: 59384061 59677936 59985533 59430941 59723695 59999044 59456603 59746454 60010418 59498228 59779239 60106398 59545464 59846864 60113045 59580433 59883622 60121142 59608030 59931290 60172116 59649580 59963196 60181079

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0398-2016

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Edwards Lifesciences

Class I - Dangerous

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

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Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

Edwards Lifesciences

Class I - Dangerous

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

May 14, 2025 Other Medical Devices Nationwide View Details →

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

Edwards Lifesciences

Class I - Dangerous

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

May 14, 2025 Other Medical Devices Nationwide View Details →