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Use caution Medical device recall · FDA · Published April 18, 2024

Boston Scientific Vercise Genus DBS IPG Recall: Device Reset May Cause Temporary

Boston Scientific recalls Vercise Genus Deep Brain Stimulation implantable pulse generators with specific model numbers due to potential device reset during charging, which may cause temporary loss of stimulation and worsened symptoms.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1890-2024Medical deviceBoston Scientific ›
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Contact the company

Recalling firmBoston Scientific Neuromodulation Corporation25155 Rye Canyon Loop · Valencia, CA 91355-5004
✎ GovInfoNow plain-language explainer

Boston Scientific is recalling Vercise Genus Deep Brain Stimulation implantable pulse generators (IPGs) with specific model numbers. The recall is due to a potential device reset during charging that could cause temporary loss of stimulation, leading to worsened movement disorder symptoms or patient requests for surgical revision. Read more at govinfonow.com/recall/55351-boston-scientific-vercise-genus-dbs-ipg-recall-device-reset-may.

Source Summary by GovInfoNow · govinfonow.com/recall/55351-boston-scientific-vercise-genus-dbs-ipg-recall-device-reset-may · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1890-2024

Cite this page

“Boston Scientific Vercise Genus DBS IPG Recall: Device Reset May Cause Temporary.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55351-boston-scientific-vercise-genus-dbs-ipg-recall-device-reset-may. Based on FDA recall #Z-1890-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1890-2024%22&limit=1).

The FDA announced on April 18, 2024, that Boston Scientific Neuromodulation Corporation is voluntarily recalling Vercise Genus Deep Brain Stimulation Implantable Pulse Generators. The devices may reset during routine checks, potentially causing a loss of stimulation and worsening movement disorder symptoms.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG
  • Models: R16 IPG KIT (REF: M365DB12160), R32 IPG KIT (REF: M365DB12320)
  • UPC/UDI-DI: 8714729985044, 8714729985051
  • Serial Number Range: 100209 - 753347 (REF M365DB12160); 100104 - 753200 (REF M365DB12320)
  • Expiration Date Range: 09-OCT-2020 through 26-MAR-2026 (REF M365DB12160); 09-OCT-2020 through 21-MAR-2026 (REF M365DB12320)
  • Units Affected: 14,977
  • Distribution: Worldwide including US states TX, WA, MT, GA, TN, MA, OR, ID, CA, FL, WI, UT, DE, AZ, PA, DC, LA, KY, VA, MN, NC, OH, NY, MI, CO, IN, MD, NV, AL, IL, AR, SC, OK, MO, MS, NJ, ME, Hi, KS, SD, WV, NM, AK, CT, WY, NE, ND and countries Canada, Argentina, Chile, Colombia, Brazil, Algeria, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Italy, Jordan, Kazakhstan, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, Australia, Thailand, Singapore, Hong Kong, Korea, India, Japan

The hazard

The device may experience a routine system check during IPG charging that causes a device reset. This reset could lead to transient loss of stimulation, causing patients to experience undesired sensations or transient worsening of movement disorder symptoms. These issues may lead patients to request surgical intervention for replacement or revision.

Context

GovInfoNow's records show Boston Scientific Neuromodulation Corporation has 12 other recalls on record since April 24, 2019. Other recent recalls of similar products include the Boston Scientific INFINION CX Lead Kits Recall (June 17, 2026), the Boston Scientific TCN Electrodes May Not Meet Performance Levels recall (April 29, 2026), and the Boston Scientific SC-4318 Clik X Anchor Recall (April 29, 2026). Other recent recalls of similar products include the Philips Incisive CT Recall (December 3, 2025), the Inspire Stimulation Lead Recall (May 11, 2026), and the Boston Scientific LUX-Dx Cardiac Monitor System Recall (August 6, 2026).

How to tell if you have this one

Check for the model numbers R16 IPG KIT (REF: M365DB12160) or R32 IPG KIT (REF: M365DB12320). The serial numbers range from 8714729985044 to 8714729985051 with expiration dates between October 2020 and March 2026.

  • Brand
    Boston Scientific
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Identify if your IPG is one of the recalled models (R16 or R32) with the specified serial number ranges.

  2. Contact Manufacturer

    Reach out to Boston Scientific for guidance on next steps if you have a recalled device.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 46 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution including in the states of TX, WA, MT, GA, TN, MA, OR, ID, CA, FL, WI, UT, DE, AZ, PA, DC, LA, KY, VA, MN, NC, OH, NY, MI, CO, IN, MD, NV, AL, IL, AR, SC, OK, MO, MS, NJ, ME, Hi, KS, SD, WV, NM, AK,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Apr 18, 202412. FDA classified it Class II: May 24, 202423. Published in FDA’s Enforcement Report: Jun 5, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-1890-2024 (April 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1890-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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