MINNEAPOLIS, MN—A change implemented on one manufacturing line at Medtronic has resulted in damaged pouches on IN.PACT Admiral and IN.PACT AV balloon catheters, forcing the company to recall some of the products. Damaged pouches can lessen catheter sterility.
Medtronic says that the problem has since been fixed, and production on the line fully restored. Both products are Paclitaxel-coated percutaneous transluminal angioplasty catheters.
The recall affects 6,000 Admiral and three AV catheters. Medtronic is telling customers to “immediately quarantine and return the product to Medtronic, as well as send back a signed confirmation form.”
Thus far, Medtronic has received no complaints due to the issue and there have been zero reports of patient injuries or deaths. The company says that no action is needed from patients where the affected IN.PACT Admiral and IN.PACT AV catheters were used during a procedure.