Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Pro
FDA device recall Z-2082-2025 · posted 2025-07-10 · Open, Classified
Recall details
- Recalling firm
- 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.
- Action taken
- 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 this notice with appropriate clinical staff at their site. " No patient follow-up or notification is necessary. " Return a completed Customer Acknowledgment Form to Edwards eCV Representative or via email to Edwards Customer Service at FCA_ECV@edwards.com within 15 days of receipt of this notification. " After receiving RGA number, return any impacted product to Edwards at the address below. A credit will be issued upon receipt of returned product. enableCV Distribution Center 6644 W. 2100 S. Suite D West Valley, UT 84128 For questions/assistance contact - Customer Service at 1-888-943-2783, or email: FCA_ECV@edwards.com
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DQR
- Quantity affected
- 6801
- Distribution
- Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINO
- Date initiated
- 2025-05-14
- Date posted
- 2025-07-10
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII (K140208) | Edwards Lifesciences, LLC | 2014-03-05 |