FDA designates recall of balloon catheter for PTA as class 1

The FDA has designated Cook Medical’s product recall of a balloon catheter used for percutaneous transluminal angioplasty as a class 1 recall, the most serious kind. The recall affects 33 devices manufactured and distributed between Oct. 3 and March 21.

There have been several complaints that the balloon (Advance Enforcer 35 Focal-Force PTA balloon catheter 6 mm x 4 cm) burst below the rated burst pressure, which may result in an additional intervention, delay in the procedure, balloon fragmentation in the patient, vessel injury and death, according to a MedWatch report from the FDA. There have been no reports of deaths, malfunctions or injury associated with this issue.

Cook Medical distributed a notice to customers May 24 alerting them to examine their inventory, return affected products and to complete an acknowledgement and receipt form, in addition to alerting appropriate personnel of the issue and to immediately report adverse events to the company