AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I Recall
AUDIENCE: Risk Manager, Cardiology
ISSUE: 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.
This recall affects 17,682 units distributed from 09/2007 to 11/2010, including the following model part (REF) numbers and includes all sizes and lot codes for each model listed: 2076-4020, 2076-5020, 2076-6020, 2092-6020, 2105-6020.
BACKGROUND: 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.
RECOMMENDATION: AngioScore Inc. is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[01/05/2011 - Recall Notice - FDA]