Medtronic is voluntarily recalling certain balloon dilation catheters that have proven difficult to remove from patients’ bodies.
The recall affects a subset of the company’s Euphora and Solarice semi-compliant rapid exchange balloon dilatation catheters manufactured from February 27, 2019, through July 31, 2019, according to a letter sent to customers.
Medtronic said that some of the catheters’ stylettes have a slightly higher diameter, which may hamper removal. If the physician applies excessive force, the balloon or catheter may be damaged and the balloon could be difficult to inflate or deflate. Either situation could lengthen procedure time or create the need for additional intervention. Inflation or deflation difficulties could also injure the patient’s vessel, the company said.
Medtronic said it had received 14 customer complaints, which represent 0.012% of affected product sold. One injury was reported to the company through August 19, 2019, the letter said.