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Lower risk Medical device recall · FDA · Published June 6, 2025

Boston Scientific Superion Indirect Decompression System: Performance Issues

Boston Scientific recalls Superion Indirect Decompression System kits (8mm-16mm) due to inconsistent performance, including breakage of instruments and implants. Affected units have specific lot/batch numbers listed in the recall notice.

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

🇺🇸 FDA recall #Z-2485-2025Medical 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 Superion Indirect Decompression System kits (8mm to 16mm) because the devices and instruments don't consistently meet expected performance levels, leading to breakage. This could affect surgical procedures and patient safety. Read more at govinfonow.com/recall/52140-boston-scientific-superion-indirect-decompression-system-performance-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/52140-boston-scientific-superion-indirect-decompression-system-performance-issues · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2485-2025

Cite this page

“Boston Scientific Superion Indirect Decompression System: Performance Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52140-boston-scientific-superion-indirect-decompression-system-performance-issues. Based on FDA recall #Z-2485-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2485-2025%22&limit=1).

The FDA announced on June 6, 2025, that Boston Scientific Neuromodulation Corporation is recalling its Superion Indirect Decompression System kits and associated instruments due to performance issues including breakage. The agency issued recall number Z-2485-2025 for the voluntary Class II recall affecting approximately 70,516 units distributed nationwide.

How to tell if you have it

  • Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529
  • Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536
  • Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543
  • Superion Indirect Decompression System 14MM, VF Implant 101-9814 00884662000550
  • Superion Indirect Decompression System 16MM, VF Implant 101-9816 00884662000567
  • Superion Indirect Decompression System Kit, VF Instrument 102-9800 00884662000574
  • The Vertiflex Procedure Instrument Platform, VF Instrument 140-9800 00884662000611

The hazard

According to the FDA, a comprehensive product performance review determined that the device and instruments are not consistently meeting expected performance levels. The identified issues include breakage of the instruments and implant/device.

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 CSK Electrodes 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 Boston Scientific Rapid Refill System recall (June 30, 2026) and the Boston Scientific AXIOS Stent Recall (December 19, 2025).

How to tell if you have this one

Check the product label for the model number (8mm, 10mm, 12mm, 14mm, or 16mm Superion Indirect Decompression System) and the lot/batch numbers listed in the recall notice. The recall covers specific lot/batch numbers for each model.

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

What to do — step by step

  1. Check Product Label

    Look for the model number (8mm, 10mm, 12mm, 14mm, or 16mm Superion Indirect Decompression System) and the lot/batch numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 48 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew 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: “U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, 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, SC, SD, TN, TX, UT, VA,…” 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, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Jun 6, 202512. FDA classified it Class II: Sep 2, 202523. Published in FDA’s Enforcement Report: Sep 10, 202532025
  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-2485-2025 (June 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2485-2025 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