Skip to content

Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula… recallZ-1371-2015 · Edwards Lifesciences, LLC · initiated Mar 23, 2015

Class II Terminated All recalls posted in April 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Edwards Lifesciences, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding wire located at the tip of the cannula.

FDA root cause category: Process change control

What the company is doing

The firm, Edwards, sent an "URGENT - PRODUCT RECALL - ACTION REQUIRED" letter dated March 23, 2015 via FED EX on March 27, 2015 to their customers. The letter described the product, problem, and actions to be taken. The customers were instructed to review entire inventory for the lots listed; complete and return attached acknowledgment form via fax to Edwards Customer Service at 800.422.9329. within three days of receipt of this Field Safety Notice; contact Customer Service at 800.422.3278 to obtain an RGA number and replacement product; return affected product to Edwards Lifesciences, Attn: Cirilo Chaparro, 12050 Lone Peak Drive, Draper, UT 84020, Attention: RECALL, RGA#XXX; and transfer this notice to other organizations if the affected devices have been transferred to any another facilities. If you have any questions that have not been answered by this letter, please call Edwards Customer Services at 800.424.3278 from the hours of 6:00AM - 4:30PM PST; Edwards Customer Service at (800) 268-3993 from 8:00AM 4:30PM Eastern Time or contact your Edwards sales representative concerning the recall.

Recall details

Recall number
Z-1371-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 23, 2015
Posted by the FDA
Apr 2, 2015
Recalling firm
Edwards Lifesciences, LLC
Quantity
5125 units
Product code
DWF
FDA submissions
K140208
Distribution
Nationwide Distribution.

Product description

Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures.

Code information (models, lots, serial numbers)

Model/Lot Numbers: FEMII008A/59751073, 59775775, 59775776, 59775777 & 59852930; FEMII008AT/59807985, 59867050, & 59873263;  FEMII008V/59873250 & 59873251; FEMII010A/59740468, 59773806, 59792415, 59792416 & 59852934;  FEMII010AT/ 59747819, 59807986,59852935, 59890916 & 59896910; FEMII010V/59751074, 59849119 & 59890924; FEMII012A/ 59801792,59867064, 59884766 & 59884778  FEMII012AT/59852940 & 59867051; and  FEMII012V/59723307, 59796683, 59849124 & 59873252

Other devices under the same FDA submission

5 devices cleared under K140208 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page