Edwards Lifesciences LLC, EMBOL-X Glide Protection System: Class I Recall
MedSun: Newsletter #89, November 2013

FDA MedWatch Safety Alert

FDA notified healthcare professionals that Edwards Lifesciences LLC issued a Class I Recall of the EMBOL-X Glide Protection System. The tip of the catheter is being recalled due to a deformed cannula tip. When force is applied to the tip during insertion or removal, it may lead to a separation and embolize. On Sept. 16, 2013 the firm sent their customers an Urgent Field Safety Notice, with instructions for quarantine and return of the affected products.

Additional Information:

Edwards Lifesciences LLC, EMBOL-X Glide Protection System: Class I Recall. FDA MedWatch Safety Alert. November 4, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm373549.htm


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