FDA recalls PTA scoring balloon catheters

AngioSculpt percutaneous transluminal angioplasty (PTA) scoring balloon catheters, manufactured by AngioScore, are subject to a class I US Food and Drug Administration(FDA) recall due to complaints of retained device fragments or significant arterial injury, which may lead to death or the need for additional surgical intervention [1].

The FDA issued the safety alert from the MedWatch FDA Safety Information and Adverse Event Reporting Program on Wednesday.

The recall affects 17 682 AngioSculpt PTA scoring balloon catheters; OTW 0.018" Platform, of multiple sizes, including the following model part numbers and including all sizes and lot codes for the following models: 2076-4020, 2076-5020, 2076-6020, 2092-6020, 2105-6020. Products were manufactured by AngioScore from September 2009 to November 2010.

A medical device recall notification letter dated November 15, 2010 was issued to US customers, who were instructed to immediately discontinue distributing and using any affected product.

The product subject to recall is used for dilatation of lesions in the iliac, femoral, iliafemoral, popliteal, infrapopliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Earlier this year, the FDA issued a class I recall for specific models of AngioScore's AngioSculpt PTCA scoring balloon catheters