Reported Nov 6, 2013 · Terminated
Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD,…
Edwards Lifesciences, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 12050 Lone Peak Pkwy · Draper, UT · 84020-9414
Is this the product you have?
- Edwards Lifesciences EMBOL-X Glide Protection System
- Model NumbersEXGF24D, 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
- Lot codes and dates
- Model No
EXGF24DEXGF24LLDEXGF24MMDEXGF24SSDEXGF24XLDEXGF24XSDEXGFXS2DEXGF24SS2DEXGF24MM2DEXGF24LL2D and EXGF24XL2D
- Model No
- Amount recalled
- 12,034
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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