MDDI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Bursting Balloon Problem Prompts Cook to Recall Catheters

No deaths or injuries have been reported, but Cook Medical has received multiple complaints of balloons bursting below the rated burst pressure on its Advance Enforcer 35 Focal Force PTA Balloon Catheters manufactured with specific balloon material lots.

The recall affects about 33 devices that were distributed to the U.S. market between October 29, 2018, to March 21, 2019. While there were no reports of malfunctions, deaths, or injury reported for this balloon issue, there is a high occurrence rate, FDA said.

Pixabay

Cook Medical recalled certain lots of a balloon catheter used for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries after receiving multiple complaints of balloons bursting below the rated burst pressure.

The company has determined that the problem affects the Advance Enforcer 35 Focal Force PTA Balloon Catheters manufactured with specific balloon material lots manufactured between October 3, 2018, and December 17, 2018.

The recall affects about 33 devices that were distributed to the U.S. market between October 29, 2018, to March 21, 2019, FDA said. While there were no reports of malfunctions, deaths, or injury reported for this balloon issue, there is a high occurrence rate, the agency said.

Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient, Cook said. 

500 characters remaining