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Lower risk Medical device recall · FDA · Published November 19, 2020

Medtronic Percept PC Neurostimulator Software Issue: Connection Failure

Medtronic recalls Percept PC implantable neurostimulators due to software failure preventing device connection. Affected units have specific model and serial numbers.

🇺🇸 FDA recall #Z-0612-2021Medical deviceMedtronic Neuromodulation ›
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Recalling firmMedtronic Neuromodulation7000 Central Ave Ne · Minneapolis, MN 55432-3568
✎ GovInfoNow plain-language explainer

What happened, in plain English

Medtronic is recalling Percept PC implantable neurostimulators because a software issue in the patient programmer prevents proper connection with the device. This could lead to improper treatment if the device isn't communicating correctly. Read more at govinfonow.com/recall/63837-medtronic-percept-pc-neurostimulator-software-issue-connection-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/63837-medtronic-percept-pc-neurostimulator-software-issue-connection-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0612-2021

Cite this page

“Medtronic Percept PC Neurostimulator Software Issue: Connection Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63837-medtronic-percept-pc-neurostimulator-software-issue-connection-failure. Based on FDA recall #Z-0612-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0612-2021%22&limit=1).

Why it’s dangerous

The software anomaly in the A620 Patient Programmer application causes the device to fail connecting with the Percept PC. This means the neurostimulator may not function properly during therapy, potentially affecting treatment effectiveness.

Who’s affected

Patients using the Percept PC neurostimulator for conditions like Parkinson's disease or essential tremor are affected. Those with the specific model numbers and serial numbers listed in the recall are most at risk.

How to tell if you have this one

Check if your Percept PC device has the model number B35200 and one of the listed serial numbers (NPI706941H through NPI706957H). The device is used for deep brain stimulation therapy for conditions like Parkinson's disease.

  • Brand
    Medtronic Neuromodulation
  • Product
    Percept PC Implantable Neurostimulator (INS)
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Connection

    Ensure the Percept PC device connects properly with the A620 Patient Programmer application. If connection fails, contact Medtronic for assistance.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 7 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Nov 19, 202012. FDA classified it Class II: Dec 16, 202023. Published in FDA’s Enforcement Report: Dec 23, 202034. FDA terminated the recall: Apr 3, 2023420202023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What are the serial numbers for the recalled devices?

The serial numbers are NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0612-2021 (November 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0612-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA