Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A.

FDA Recall Z-1467-2014 · Posted 2014-04-16

Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeDWF
Date Initiated2014-04-09
Date Terminated2016-12-28
Product Quantity28,885

Reason for Recall

Potential for separation of dilator tips.

Firm Action

Customers were notified via letter on 4/4/14 to return affected products.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide, including foreign, govt/VA/Military consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123298FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATINGEdwards Lifesciences, LLC · 2013-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑