Cook Medical recalled 12 lots of one of its peripheral catheters on reports of balloons bursting at pressures below the rated burst pressure.
In a May 24 field advisory, Bloomington, Ind.-based Cook said it received “multiple” complaints about burst balloons in its Advance Enforcer 35 Focal Force PTA balloon catheters, which are designed to treat blocked or narrowed arteries in the legs. The recall covers catheters made with specific lots of the balloon material, the company said.
The FDA gave the recall Class I status, denoting the risk of serious injury or death. Although there were no reports of malfunction, injury or deaths in connection with the burst balloon incidents, the occurrence rate was high, the agency said. Potential adverse events include procedure delay, additional intervention, vessel injury, balloon fragmentation and death, the FDA said.