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# Medtronic Recalls IN.Pact Balloon Catheters
- URL: https://www.fdaweb.com/medtronic-recalls-in-pact-balloon-catheters/
- Published: 2022-03-31T12:00:00.000Z
- Updated: 2026-09-14T17:38:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151502

Medtronic has recalled a subset of IN.Pact Admiral and IN.Pact AV paclitaxel-coated percutaneous transluminal angioplasty balloon catheters due to the potential for pouch damage and a resulting loss of sterility. The [company says](https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/inpact-medical-device-notice-update-march-2022.pdf?ref=fdaweb.com) that during a routine inspection, it detected damage to the sterile pouch that contains the devices. “An investigation determined that there had been a change implemented to one manufacturing line which may cause pouch damage,” it says. “All batches manufactured on this line after that change are being retrieved.”