🔍 RecallPedia

Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

Class I - Dangerous
🏥 Medical Devices Recalled: May 14, 2025 Edwards Lifesciences Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Code: Model No: FEMII018AS; UDI: 00690103168358; All lots up to: BSLC9064 Serial Numbers: 131776 BSLC4190 BSLC9064
  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:
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

Product Codes/Lot Numbers:

Lot Code: Model No: FEMII018AS; UDI: 00690103168358; All lots up to: BSLC9064 Serial Numbers: 131776 BSLC4190 BSLC9064

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2085-2025

Related Recalls

Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial 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: 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 →