FDA-Device2026-10-22Class IIMISBRANDING
Medtronic InterStim Percutaneous Extensions recalled for incompatibility risk
What this means
Certain Medtronic InterStim percutaneous extensions may be incompatible with some leads, preventing the neuromodulation system from functioning correctly. This incompatibility could delay surgery or require surgical replacement of the device.
- Check your InterStim device documentation to confirm whether your percutaneous extension is affected.
- Contact your healthcare provider or Medtronic if you have questions about your specific extension model.
- Do not attempt to use an incompatible lead or extension combination during any procedure.
The agency's original wording
Hazard
Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and territory of Puerto Rico. The countries of Brazil, Colombia, Chile, Canada, Japan, New Zealand, Australia, United Kingdom, Switzerland, Sweden, Spain, Portugal, Italy, Israel, Germany, France, Finland, Canary Islands, Belgium, Austria, Norway, Northern Ireland, Netherlands, Iceland, Denmark, South Africa, Turkey, Slovakia, Saudi Arabia, Poland, Hungary, United Arab Emirates (UAE), Kuwait, Greece.
Affected count
56,331 (US); 40,211 (OUS)
Manufactured in
7000 Central Ave Ne, Minneapolis, Minnesota, United States
Products
InterStim Percutaneous Extensions
EXT 3560022 ISTM II PERC
3560022
EXT 3560030 ISTM MICRO PERC
3560030
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0267-2027More Medtronic recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.