Medtronic Recalls Subset of In.Pact Admiral and In.Pact AV Drug-Coated Balloon Catheters Because of Pouch Damage

March 31, 2022—Medtronic announced it recently voluntarily recalled a subset of the company’s In.Pact Admiral and In.Pact AV paclitaxel-coated percutaneous transluminal angioplasty balloon catheters because of the potential for pouch damage resulting in a loss of sterility.

The recall affects approximately 6,000 In.Pact Admiral catheters and three In.Pact AV catheters distributed to customers globally. Medtronic is communicating to customers with affected product on hand to immediately quarantine and return the product to Medtronic, as well as send back a signed confirmation form, advised the company.

No other Medtronic products are affected by this issue. All appropriate regulatory bodies have been notified, stated the company.

According to the company, the pouch damage was discovered during a routine inspection. The cause was determined to be a change implemented to one manufacturing line. All batches manufactured on this line after that change are being retrieved. The problem on that line was fixed. Additionally, to ensure no further issues, production on all lines was paused until a follow up packaging inspection was completed. No further errors were discovered.

Medtronic advised that it has received no complaints involving this issue. There have been no reports of injury or death related to this issue. There are no actions required for patients where the affected In.Pact Admiral and In.Pact AV catheters were used during a procedure. Patients should continue to be monitored in accordance with the medical facility’s standard care protocols.

For most regions, there is little or no impact for customers to order replacement product. Customers may call Medtronic Customer service (phone: 800-551-5544, selection option “Vascular”) for any questions regarding their return or ordering replacement product, stated the company.