FDA Issues Class I Recall of Advance Enforcer PTA Balloon Catheters

Megan Brooks

June 18, 2019

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), because of 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 catheters are used for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral, and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. They are not used 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. The company is currently investigating the cause.

"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," the FDA said.

The recall affects the following specific products:

  • Advance Enforcer 35 Focal Force PTA Balloon Catheter 6 mm x 4 cm, 5FR/50 cm; catalog number ASB5-35-50-6-4; REF number G35248; lots 9234424 and 9331618

  • Advance Enforcer 35 Focal Force PTA Balloon Catheter 6 mm x 4 cm, 5FR/80 cm; catalog number ASB5-35-80-6-4; REF number G352525; lots 9212015, 9243035, 9320430, and 9386804

  • Advance Enforcer 35 Focal Force PTA Balloon Catheter 6 mm x 4 cm, 5FR/135 cm, catalog number ASB5-35-135-6-4; REF number G35252; lots 9338194, 9234423, 9278982, 9209468, 9248603, and 9320429

The catheters were manufactured between October 3, 2018, and December 17, 2018, and distributed between October 29, 2018, and March 21, 2019.

Cook Medical, the customer relations department of Cook Inc, has sent an urgent medical device recall notification letter to customers asking them to check their inventory and stop using or distributing the recalled catheters.

Customers should return the affected product(s) to Cook Medical with a copy of the acknowledgement and receipt form to receive a product credit. They should contact Stericycle at 855-205-2627 to obtain a credit and reference event number 10082.

Customers with questions may contact Cook Medical with questions or concerns regarding this recall at 812-339-2235.

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.

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