The US Food and Drug Administration (FDA) has announced a recall of the Advance Enforcer 35 Focal-Force Percutaneous PTA Balloon Catheter 6 mm x 4 cm (Cook Inc), owing to reports of the balloons bursting below the rated burst pressure.
The FDA has identified this as a Class I recall, the most serious type of recall, indicating a risk for serious injury or death.
The recalled catheter is used by healthcare providers for opening blocked or narrowed arteries that supply blood to the leg (percutaneous transluminal angioplasty (PTA)). This catheter is not for use in the cerebral or coronary vasculature.
According to the FDA, the company has received “multiple complaints” of the balloons bursting below the rated burst pressure.
“While there were no reports of malfunctions, deaths, or injury reported for this balloon issue, there is a high occurrence rate. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, balloon fragmentation in the patient, and death,” according to the FDA recall.
The catheters were manufactured between October 3, 2018, and December 17, 2018, and distributed between October 29, 2018, and March 21, 2019.
Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Adverse Event Reporting program.