CLASS II ONGOING Device recall · Reported 1 Jun 2022 · FDA Enforcement Report
Percept PC BrainSense Implantable Neurostimulator (INS) recalled
Medtronic Neuromodulation is recalling Percept PC BrainSense Implantable Neurostimulator (INS), distributed nationwide in the US. The recall was initiated on 30 Mar 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1129-2022
- FDA event ID
- 89994
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Mar 2022
- FDA classified
- 24 May 2022
- Reported
- 1 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Mar 2022 | Recall initiated by company | |
| 24 May 2022 | Classified by FDA | +55 days |
| 1 Jun 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Product as listed by the FDA
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Which lots are affected?
Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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