Packaging Issue Leads to Drug-Coated Catheter Recall

Medtronic has two FDA-approved drug-coated balloon catheters that are used to treat femoropopliteal disease and fistula stenosis. According to a recent FierceBiotech article, both the In.Pact Admiral and In.Pact AV were subject to recalls after the company identified an issue with the sterilized pouch used to package the devices. During a routine inspection, Medtronic found that a change in its manufacturing lines created risk of damage that could cause the catheters to become unsterile.