Recall Z-0266-2027 ยท QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
Medtronic Neuromodulation
InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A133 LEAD 978A141 ISTM MICRO 41CM SSMRI TINED 978A141 LEAD 978B128 ISTM II 28CM SSMRI TINED 978B128 LEAD 978B133 ISTM II 33CM SSMRI TINED 978B133 LEAD 978B141 ISTM II 41CM SSMRI TINED 978B141
| 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 | 94,441 (US); 60,488 (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.