In accordance with our commitment to patient safety, Medtronic recently voluntarily recalled a subset of its IN.PACT™ Admiral™ and IN.PACT™ AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility.
Approximately 6,000 IN.PACT Admiral catheters and 3 IN.PACT AV catheters distributed to customers globally are impacted by this recall. 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.
The pouch damage was discovered during a routine inspection. Upon investigation, a change implemented to one manufacturing line was determined to be the cause. All batches manufactured on this line after that change are being retrieved. The problem on that line was fixed. Additionally, to ensure that no further issues, production on all lines was paused until a follow up packaging inspection was completed. No further errors were discovered.
Medtronic has received zero (0) complaints involving this issue. There have been zero (0) 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 reach out to Medtronic Customer service (800-551-5544, selection option “Vascular”) for any questions regarding their return or ordering replacement product.
No other Medtronic products are affected by this issue. All appropriate regulatory bodies have been notified.