Recall Z-0267-2027 ยท EZW Stimulator, Electrical, Implantable, For Incontinence
Medtronic Neuromodulation
InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
| Date | Oct 22, 2026 (initiated Sep 8, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Firm began distributing Urgent Medical Device Correction letters to consignees via email or mail starting 9/15/26. The letter included recommendations for system and patient management: - Verify InterStim product names and model numbers are compatible prior to the procedure. - Review letter for a summary of compatible product information. - Consult the System Overview and Compatibility Insert at www.manuals.medtronic.com for additional product compatibility information. - Ensure a system integrity check is performed prior to completing the implant procedure per the applicable product manual. |
| Quantity | 56,331 (US); 40,211 (OUS) |
| Distribution | 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 Irel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.