Edwards Lifesciences, LLC: Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A 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

Recall number

Z-2082-2025

Recalling firm

Edwards Lifesciences, LLC

Product

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A 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

Status

Open, Classified

Initiated

2025-05-14

Posted

2025-07-10

Terminated

not on file

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 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

Quantity

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, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY, LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO, NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, Puerto Rico, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN and the countries of Albania, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta, Netherlands, Northern Ireland, Norway, Pakistan, Panama, Poland, Portugal, Romania, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates (UAE), United Kingdom.

Lot, serial or model codes

Lot Code: Model No: FEMII016A; UDI: 00690103031232; All lots up to: BSLC8179 Serial Numbers: 130544 130757 131105 131313 131511 131535 131888 131925 132504 BSLC0184 BSLC0386 BSLC0596 BSLC1311 BSLC3741 BSLC4162 BSLC5040 BSLC6487 BSLC8179

510(k) numbers

["K140208"]

PMA numbers

not on file

Product code

DQR

Firm FEI

2015691

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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