Edwards Lifesciences, LLC: Medical Device Recall in 2013 - (Recall #: Z-0091-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class I

Date Initiated: September 16, 2013

Date Posted: November 6, 2013

Recall Number: Z-0091-2014

Event ID: 66305

Reason for Recall:

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

Status: Terminated

Product Quantity: 12,034

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.

Voluntary or Mandated:

Voluntary: Firm initiated