Edwards Lifesciences EMBOL-X Glide Protection System — Class I medical device recall Z-0091-2014
Terminated recall by Edwards Lifesciences, LLC, reported 2013-11-06, distributed nationwide. Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the ca
| Recall number | Z-0091-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2013-09-16 |
| Classified | 2013-10-31 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2017-03-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 12,034 |
| Model numbers | EXGF24D, EXGF24LL2D, EXGF24LLD, EXGF24MM2D, EXGF24MMD, EXGF24SS2D, EXGF24SSD, EXGF24XL2D, EXGF24XLD, EXGF24XSD, EXGFXS2D |
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.
Reason for recall
Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.