Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Reported: June 1, 2022 Initiated: March 30, 2022 #Z-1129-2022
Product Description
Percept PC 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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 1 unit
- 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.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200. Recalled by Medtronic Neuromodulation. Units affected: 1 unit.
Why was this product recalled? ▼
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 1, 2022. Severity: Moderate. Recall number: Z-1129-2022.
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