Device 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.
Z-0091-2014
Product summary
- Event
- Event 66305
- Status
- Terminated
- Classification
- Class I
- Quantity
- 12,034
- Official record key
device-enforcement:Z-0091-2014
Official wording
Reason: Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.
Code information: Model No: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.
Distribution pattern: Worldwide distribution: US (nationwide) and country of: Canada.
Derived failure modes
-
Unknown
Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.