FDA Device recall Z-1466-2014

Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS,…

FDA Device
Class II
terminated
Published 2014-04-23

On 2014-04-23 the FDA classified a Class II recall of Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS,… by Edwards Lifesciences, citing potential for separation of dilator tips.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1466-2014
Classification	Class II
Status	terminated
Initiated	2014-04-09
Published	2014-04-23
Last updated	2026-09-13 11:53 UTC
Company	Edwards Lifesciences
Distribution	US

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.

Reason

Potential for separation of dilator tips.

Identifiers

code_info	FEMII016A - 59028126, 59049696, 59069370, 59077178, 59090422, 59103195, 59124013, 59138579, 59142234, 59151373, 5917626… 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, 59304

code_info

FEMII016A - 59028126, 59049696, 59069370, 59077178, 59090422, 59103195, 59124013, 59138579, 59142234, 59151373, 5917626…

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, 59304

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1466-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.