AngioScore Inc. recalled its 0.018″ OTW-design AngioSculpt PTA scoring balloon catheter.
"A small number" of the devices fragmented while in use, and though no injuries have been reported, the Food & Drug Administration branded the recall as Class I.
The watchdog agency classifies recall actions as Class I when using the product in question may cause serious injury or death. Failure of the device could result in "significant arterial injury due to device failure may occur which may lead to death, need for percutaneous catheter-based interventions to remove retained device fragments, increased exposure to anesthesia and loss of limb," according to the company.
Fremont, Calif.-based AngioScore’s global recall affects its 4.0x20mm, 5.0x20mm, and 6.0x20mm-sized balloons, comprising 14,775 products in the United States and 2,907 outside the country, the company said.
The percutaneous transluminal angioplasty platform is indicated for treatment of lesions in the iliac, popliteal, infra popliteal, femoral, ilia-femoral and renal arteries, in addition to the the dilation of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, according to the FDA recall notice.