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Use caution Medical device recall · FDA · Published July 17, 2024

Boston Scientific WAVEWRITER ALPHA SCS Implantable Pulse Generator Recall: Temporary

Boston Scientific recalls WAVEWRITER ALPHA spinal cord stimulation devices with specific model numbers due to potential temporary loss of therapy causing discomfort and possible surgical intervention requests. Affected units have unique reference codes and serial numbers.

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

🇺🇸 FDA recall #Z-2617-2024Medical 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 specific models of spinal cord stimulation devices that may temporarily stop therapy for 10-15 seconds during charging. This could cause discomfort and lead patients to request surgery if they experience the interruption frequently. Read more at govinfonow.com/recall/54601-boston-scientific-wavewriter-alpha-scs-implantable-pulse-generator-recall-temporary.

Source Summary by GovInfoNow · govinfonow.com/recall/54601-boston-scientific-wavewriter-alpha-scs-implantable-pulse-generator-recall-temporary · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2617-2024

Cite this page

“Boston Scientific WAVEWRITER ALPHA SCS Implantable Pulse Generator Recall: Temporary.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54601-boston-scientific-wavewriter-alpha-scs-implantable-pulse-generator-recall-temporary. Based on FDA recall #Z-2617-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2617-2024%22&limit=1).

The FDA announced on July 17, 2024, that Boston Scientific Neuromodulation Corporation is recalling WAVEWRITER ALPHA implantable pulse generators due to a potential device reset during charging. This reset may cause a transient loss of stimulation for patients.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: WAVEWRITER ALPHA
  • Model: SC-1216, 16 IPG KIT, REF: M365SC12160
  • Model: SC-1232, 32 IPG KIT, REF: M365SC12320
  • REF/UDI-DI(GTIN)/Serial Number Range: M365SC12160/8714729985082/100188 - 758920
  • REF/UDI-DI(GTIN)/Serial Number Range: M365SC12320/8714729985099/100635 - 759404

The hazard

The FDA said the Spinal Cord Stimulation Implantable Pulse Generator may experience a routine system check during charging that causes a device reset. This may lead to a transient loss of stimulation, causing patients to experience undesired sensations when therapy turns off for approximately 10-15 seconds and then back on.

Context

GovInfoNow's records show Boston Scientific Neuromodulation Corporation has had 12 other recalls 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 Olymp ShockPulse-SE Lithotripsy System Generator Recall (Nov. 14, 2025), the Boston Scientific Rapid Refill System recall (June 30, 2026), and the GE Healthcare Carestation Anesthesia System Power Board Recall (Nov. 14, 2025).

How to tell if you have this one

Check for model numbers SC-1216 (16 IPG Kit) or SC-1232 (32 IPG Kit) with reference codes M365SC12160 or M365SC12320. The serial numbers range from 8714729985082 to 758920 for the first model and 8714729985099 to 759404 for the second.

  • 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 device is model SC-1216 or SC-1232 with the specified reference codes.

  2. Contact Manufacturer

    Reach out to Boston Scientific for guidance on device status and potential remedies.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 49 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: 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: named in the noticeIAIndiana: 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 noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide Distribution: US (nationwide) including states of: TN, PA, WA, SC, MN, OH, NC, AK, NY, IL, CA, NJ, KY, IA, MO, UT, FL, IN, LA, AL, MS, MD, WI, GA, VA, TX, AZ, KS, OR, CO, CT, ID, AR, OK, MA, MI, ND, NE, SD, WV, NV, HI, NH, DC,…” 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, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 35 days after the firm started it.

1. Firm started the recall: Jul 17, 202412. FDA classified it Class II: Aug 14, 202423. Published in FDA’s Enforcement Report: Aug 21, 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-2617-2024 (July 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2617-2024 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