Z-2083-2025Class I

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software...

Name: Z-2083-2025 Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software...
Creator: Edwards Lifesciences, LLC
Published: 2025-05-14
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2025-05-14 / Open, Classified

FDA source

Edwards Lifesciences, LLC began a recall of Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards... on 2025-05-14. FDA classified it as Class I and gives the reason as "due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2083-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-05-14
Posted: 2025-07-10
Recalling firm: Edwards Lifesciences LLC
Product: 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
Product code: DQR Cannula, Catheter
Reason for recall: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
FDA 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 [email protected] 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: [email protected]
Quantity in commerce: 847
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.
Product codes and lots: Lot Code: Model No; FEMII016AS; UDI: 0060913168341; All lots up to: BSLC1689 Serial Numbers: FEMII016AS FEMII016AS FEMII016AS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2083-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2080-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-10
Z-2081-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-10
Z-2082-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-10
Z-2083-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-10
Z-2084-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-10
Z-2085-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-10

Product code DQR

K140208Class IIFerm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,vfem, and Fem-FlexiiEdwards Lifesciences, LLC / cleared 2014-03-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)