Medtronic Recalls Certain Balloon Catheters Due to Risk of Nonsterility

Medtronic is recalling some of its In.Pact Admiral and In.Pact AV paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters because of the potential for damage to the pouch resulting in a loss of sterility.

The pouch damage was discovered during a routine inspection, Medtronic said. Upon investigation, a change implemented to one manufacturing line was determined to be the cause. All batches manufactured on the line after that change are being retrieved.

The problem on the line was fixed and “no further errors were discovered,” the company said, adding that it had received no complaints and no reports of injury or death related to the problem.