Medtronic Issues Voluntary Recall for Certain In.Pact Drug-Coated Balloon Catheters

Medtronic (NYSE: MDT) today announced the voluntary recall of a subset of its In.Pact Admiral and In.Pact AV balloon catheters.

The company initiated the recent recall of paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the risk of damage to the pouch leading to loss of sterility.

According to the company, approximately 6,000 In.Pact Admiral catheters and three In.Pact AV catheters distributed to customers worldwide are affected by the recall. To date, the company has not received any complaints regarding this issue and there have been no reports of injuries or fatalities related to this issue.

Medtronic discovered damage to the bag during a routine inspection. Further investigation revealed that a change implemented on a manufacturing line was the cause. All batches made on the line after the change are recovered and the issue on that line has been resolved, the company said. Additionally, to ensure that further issues do not arise, Medtronic has suspended production on all lines until a follow-up packaging inspection is completed and no additional errors are discovered. .

No action is required for patients in whom the affected In.Pact Admiral and In.Pact AV drug-coated balloon catheters were used during a procedure. Medtronic said it is communicating to customers with the affected product on hand to immediately quarantine and return the product with a signed confirmation form.