Z-1466-2014Class II

Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French...

Name: Z-1466-2014 Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French...
Creator: Edwards Lifesciences, LLC
Published: 2014-04-09
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2014-04-09 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A... on 2014-04-09. FDA classified it as Class II and gives the reason as "Potential for separation of dilator tips". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1466-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-09
Posted: 2014-04-16
Terminated: 2016-12-28
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Potential for separation of dilator tips.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers were notified via letter on 4/4/14 to return affected products.
Quantity in commerce: 13,115
Distribution: Nationwide, including foreign, govt/VA/Military consignees.
Product codes and lots: FEMII016A - 59028126, 59049696, 59069370, 59077178, 59090422, 59103195, 59124013, 59138579, 59142234, 59151373, 59176265, 59202398, 59211445, 59218739, 59229566, 59232164, 59240932, 59266788, 59276834, 59312966, 59315604, 59342283, 59369388, 59409771, 59444473, 59468377, 59477867, 59499493, 59504222, 59504265, 59509409, 59551227, 59555094, 59563825, 59563881, 59589947, 59589952, 59609154, 59627646, 59630590, 59635736, 59635737, 59651804, 59662630, 59680124, 59680182, 59684469, 59691508 FEMII016AS - 59047478, 59112421, 59183047, 59229541, 59271782, 59394860, 59463345, 59593794 FEMII018A - 59021243, 59035354, 59043578, 59060761, 59060762, 59062270, 59064759, 59070872, 59079659, 59081681, 59082564, 59092366, 59093899, 59107280, 59114713, 59118388, 59124014, 59126280, 59138577, 59142229, 59142233, 59149665, 59169476, 59173958, 59173973, 59191995, 59210228, 59211444, 59211451, 59218738, 59222629, 59229567, 59235556, 59235558, 59254373, 59261612, 59271772, 59274361, 59299840, 59304350, 59304353, 59315607, 59332980, 59350864, 59379048, 59383856, 59400071, 59437566, 59437567, 59448621, 59458038, 59468821, 59477813, 59477838, 59490065, 59509300, 59509407, 59516176, 59528326, 59546034, 59551226, 59555043, 59555095, 59568507, 59577160, 59581459, 59585855, 59593828, 59604721, 59604722, 59604768, 59615024, 59616140, 59634860, 59634914, 59640034, 59640111, 59645315, 59648786, 59651807, 59651818, 59651905, 59680127, 59680192, 59684473, 59691468, 59691497 FEMII018AS- 59442433, 59551221, 59662385, 59684809 FEMII020A - 59442434, 59444471, 59458044, 59473388, 59477822, 59484137, 59492047, 59509404, 59514153, 59518778, 59523721, 59528327, 59528328, 59551224, 59555098, 59558960, 59572973, 59581458, 59581565, 59585993, 59593791, 59593830, 59599145, 59599177, 59615023, 59616141, 59620333, 59640098, 59641413, 59641415, 59648784, 59651907, 59651909, 59662631, 59670296, 59680176, 59691467, 59702375, FEMII020AS - 59473385, 59555025, 59675123.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1466-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1466-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-16
Z-1467-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-16

Product code DWF

K123298Class IIFem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo CoatingEdwards Lifesciences, LLC / cleared 2013-03-15

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)