Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD

FDA device recall Z-0091-2014 · posted 2013-10-31 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, LLC

Reason for recall

Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.

Action taken

The firm, Edwards Lifesciences, sent an "URGENT FIELD SAFETY NOTICE PRODUCT RECALL-ACTION REQUIRED" letter dated September 16, 2013 via Fed-Ex to its consignees/customers. Consignees were asked to review inventory for the cannulae and remove the cannulae from any kits received; quarantine affected material at site and return product to Edwards LIfesciences, Attn: Santosh Bhagat, 12050 Lone Peak Drive, Draper, UT 84020, Attention: RECALL, RGA #; call Edwards Customer Service at 800-424-3278 to obtain RGA# and replacement product (note: the filter is not affected and does not have to be returned with the cannulae); and complete and return the attached acknowledgment form via fax to Edwards Customer Service at 800-422-9329 within three days of receipt of this Field Safety Notice. If you have any questions, please call Edwards Customer Service at 800-424-3278 from the hours 6:00am - 4:30pm PST or contact your Edwards' sales representative concerning the recall.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DWF

Quantity affected

12,034

Distribution

Worldwide distribution: US (nationwide) and country of: Canada.

Date initiated

2013-09-16

Date posted

2013-10-31

Date terminated

2017-03-10

Location

Draper, UT

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