Edwards Lifesciences Research Medical, Inc. Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardiopulmonary bypass tubing. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardiopulmonary bypass tubing.
Brand
Edwards Lifesciences Research Medical, Inc.
Lot Codes / Batch Numbers
Lot 58458668
Products Sold
Lot 58458668
Edwards Lifesciences Research Medical, Inc. is recalling Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardi due to Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this pr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significant delay and has the potential to result in a permanent injury.
Recommended Action
Per FDA guidance
Consignees were notified by Edwards Lifesciences sales representatives and a Product Recall letter dated 2/22/08. Users were instructed to check their inventory for any affected product and to return all unused product to the recalling firm. Users were also requested to return a recall response form indicating the quantity of affected product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026