Medtronic (NYSE:MDT) announced today that it voluntarily recalled a subset of its In.Pact Admiral and In.Pact AV balloon catheters.
The company initiated the recent recall of the paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility.
According to the company, approximately 6,000 In.Pact Admiral catheters and three In.Pact AV catheters distributed to customers globally are impacted by the recall. To date, the company has received zero complaints involving the issue and there have been zero reports of injury or death related to the issue.
Medtronic discovered pouch damage during a routine inspection. Further investigation found that a change implemented to one manufacturing line was the cause. All batches manufactured on the line after the change are being retrieved and the issue on that line has been fixed, the company said. Additionally, to ensure further issues don’t arise, Medtronic paused production on all lines until a follow-up packaging inspection was completed and no additional errors were discovered.
There are no actions required for patients for 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 affected product on hand to immediately quarantine and return the product and a signed confirmation form.
