AngioScore Recalls AngioSculpt PTA Scoring Balloon Catheters Over Design Defect

More than 17,000 <"">AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018″ Platform, manufactured by AngioScore Inc. of California, are subject to a Class I recall due to a design defect. That defect could lead to potentially fatal arterial injuries, according to a posting on the Food & Drug Administration (FDA) website.

Class I recalls are the FDA’s 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.

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.

This recall affects 17,682 units distributed from 09/2007 to 11/2010. It includes 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

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. According to the recall notice, use of affected devices may lead to retained device fragments or significant arterial injury. This can lead to death or the need for additional surgical intervention.

AngioScore is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product.

AngioScore 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.

Questions or concerns about this recall 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.

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