AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018' ' Platform - Class I Recall
MedSun: Newsletter #57, February 2011

FDA MedWatch Safety Alert

The device was recalled because of a design defect causing unintended fracture and peeling, and has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. Use of affected devices may lead to retained device fragments or significant arterial injury which may lead to death, or need for additional surgical intervention. AngioScore Inc. is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product.

Additional Information:

FDA MedWatch Safety Alert. AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I Recall. January 5, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239029.htm


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