Edwards—EMBOL-X Glide Protection System Cannulae: Tip May Be Deformed

ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a September 16, 2013, Urgent Field Safety Notice letter submitted by ECRI Institute member hospitals, Edwards states that the tip of the cannulae below may be deformed, potentially putting the patient at risk. Edwards also states that it has received reports of this problem occurring; however, it has received no reports of patient injury associated with this problem. The manufacturer has not confirmed the...