AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon CatheterOTW 0.018" Platform (multiple sizes)
Recall Class: Class I
Date Recall Initiated: November 15, 2010
Product(s): The AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, multiple sizes.
This recall includes the following model part (REF) numbers and includes all sizes and lot codes for each model listed:
This recall affects 17,682 units distributed from 09/2007 to 11/2010.
AngioScore Inc. sent Medical Device Recall notification letters to all domestic customers on Nov. 15, 2010 by overnight mail. The recall letters list the affected product with description, part numbers and that all lots are affected. They describe the reason for recall and the potential harm to patients.
Reason for Recall: Design defect causing unintended fracture and peeling which 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.
Use: The AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, is used for dilatation of lesions in the iliac, femoral, ilia-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
5055 Brandin Ct
Fremont, CA 94538
AngioScore Inc., Customer Service at 877-264-4692
FDA District: San Francisco
AngioScore Inc. is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product.
An inventory form provided by the company should be completed and returned by fax to AngioScore at 866-520-1945 to initiate product return.
Questions or concerns should be directed to AngioScore Customer Service at 877-264-4692, Monday through Friday from 8:00am to 5:00 pm (Pacific Time), or contact the local service rep.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.