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U.S. Department of Health and Human Services

Class 1 Device Recall FEMFLEX II

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 Class 1 Device Recall FEMFLEX IIsee related information
Date Initiated by FirmMay 14, 2025
Date PostedJuly 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2082-2025
Recall Event ID 96943
510(K)NumberK140208 
Product Classification Cannula, catheter - Product Code DQR
ProductBrand 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
Code Information 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
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information ContactDannette Crooms
1-801-8424930
Manufacturer Reason
for Recall		due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce6801
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DQR
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