Z-0091-2014Class I

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

Name: Z-0091-2014 Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD...
Creator: Edwards Lifesciences, LLC
Published: 2013-09-16
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2013-09-16 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D... on 2013-09-16. FDA classified it as Class I and gives the reason as "Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip". 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-0091-2014
Classification: Class I
Status: Terminated
Initiated: 2013-09-16
Posted: 2013-10-31
Terminated: 2017-03-10
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 12,034
Distribution: Worldwide distribution: US (nationwide) and country of: Canada.
Product codes and lots: Model No: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0091-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0091-2014	Class I	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-31

Product code DWF

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)