# FDA recall Z-1128-2022

> **Medtronic Neuromodulation** · Class II · device recall initiated 2022-03-30.

## Product

Percept BrainSense Implantable Neurostimulator (INS), Model B35200

## Reason for recall

The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of  AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,  VA, VT,  WA, WI, WV, WY and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.

## Key facts

- **Recall number:** Z-1128-2022
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-30
- **Report date:** 2022-06-01

- **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-1128-2022

## Citation

> AI Analytics. FDA recall Z-1128-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1128-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*