# FDA recall Z-2159-2021

> **Medtronic Neuromodulation** · Class II · device recall initiated 2021-07-09.

## Product

Medtronic Vectris SureScan MRI, Catalog Numbers:  a) 977A260  b) 977A275  c) 977A290

## Reason for recall

Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.

## Distribution

Austria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom

## Key facts

- **Recall number:** Z-2159-2021
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-09
- **Report date:** 2021-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2021

## Citation

> AI Analytics. FDA recall Z-2159-2021. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2159-2021. Source: US FDA. Licensed CC0.

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