# Class II recall Z-0266-2027: Medtronic Neuromodulation

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0266-2027 |
| Recalling firm | Medtronic Neuromodulation |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | 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 |
| 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. |
| 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 |
| Recall initiated | 2026-09-08 |
| Reported | 2026-10-28 |
| Firm location | Minneapolis, MN, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 7 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0266-2027%22). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.