Recall Z-2084-2025 ยท DQR Cannula, Catheter
Edwards Lifesciences, LLC
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
| Date | Jul 10, 2025 (initiated May 14, 2025) |
| Status | Open, Classified |
| Reason | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. |
| Root cause | Under Investigation by firm |
| Action | On 05/16/2025, and 05/19/2025, the firm sent via FedEx overnight an "URGENT: PRODUCT RECALL" Letter to customers informing them that Edwards has confirmed a small number of occurrences impacting the OptiSite Arterial Perfusion cannula in which a 3mm to 4mm section of wire, from the wire-reinforcement coil at the cannula tip, was found to be released from the cannula body. The risk for the wire-reinforcement coil protruding out of the cannula body is major tissue damage and hemolysis. Customers are instructed to: " Verify their inventory on the attached customer acknowledgement form. " Share t |
| Quantity | 13240 |
| Distribution | Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY, LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140208 | FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII Edwards Lifesciences, LLC, Mar 5, 2014 |