FDA: AngioSculpt PTA Balloon Catheter Platform Recalled
Design defect may result in death or the need for additional surgical intervention
THURSDAY, Jan. 6 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care professionals of a recall of AngioScore Inc.'s AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform, as a design defect may result in retained device fragments or significant arterial injury that could result in death or the need for additional surgical intervention.
The AngioSculpt PTA Scoring Balloon Catheter OTW 0.018" Platform is indicated for the dilatation of lesions in the iliac, popliteal, infra popliteal, femoral, ilia-femoral, and renal arteries, as well as for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The recall was issued because a design defect may result in peeling of the bond and/or detachment of the distal end of the scoring element, which upon use may lead to retained device fragments or significant arterial injury.
The recall affects 17,682 units distributed between September 2007 and November 2010. The model part (REF) numbers of the units being recalled include 2076-4020, 2076-5020, 2076-6020, 2092-6020, and 2105-6020. The REF numbers being recalled include all sizes and lot codes for each model listed.
According to the FDA, "AngioScore Inc. is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product."