FDA Class I Recall for PTA Catheters Due to Unexpected Balloon Bursting

Cook Medical is recalling a percutaneous transluminal angioplasty (PTA) catheter due to problems associated with balloons bursting below the rated burst pressure. The US Food and Drug Administration announced today that it has deemed it a Class I device recall, the most serious type.

The recall affects the 5-Fr Advance Enforcer 35 Focal-Force PTA Balloon Catheter in 50 cm (catalog number ASB5-35-50-6-4), 80 cm (catalog number ASB5-35-80-6-4), and 135 cm (catalog number ASB5-35-135-6-4), which were distributed in the United States between October 29, 2018, and March 21, 2019. The catheters are intended for PTA of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral, and iliofemoral, as well as obstructive lesions in native or synthetic arteriovenous dialysis fistulae. They are not meant for use in the cerebral or coronary vasculature.

There have been no reports of malfunctions, deaths, or injuries reported for this balloon issue, but the company acknowledges a high rate of occurrence. The potential adverse events that may occur if an affected product is used are procedural delay, need for additional intervention, vessel injury, balloon fragmentation in the patient, and death.

Cook Medical issued notification letters to customers on May 24, 2019, urging an examination of inventory and providing information as to how they can return affected devices.