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Use caution Medical device recall · FDA · Published October 12, 2022

Boston Scientific Superion Indirect Decompression System Recall: Risk of Device Failure

Boston Scientific recalls Superion Indirect Decompression System models 101-9808, 01-9812, and 101-9814 due to potential spindle cap weld breakage that may prevent proper device deployment during surgery.

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

🇺🇸 FDA recall #Z-0230-2023Medical 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 devices with specific model numbers and sizes because they may break at a critical connection point, preventing the device from working correctly during implantation. This could lead to improper treatment of the patient's condition. Read more at govinfonow.com/recall/59926-boston-scientific-superion-indirect-decompression-system-recall-risk-of-device.

Source Summary by GovInfoNow · govinfonow.com/recall/59926-boston-scientific-superion-indirect-decompression-system-recall-risk-of-device · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0230-2023

Cite this page

“Boston Scientific Superion Indirect Decompression System Recall: Risk of Device Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59926-boston-scientific-superion-indirect-decompression-system-recall-risk-of-device. Based on FDA recall #Z-0230-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0230-2023%22&limit=1).

The FDA announced on 2022-10-12 that Boston Scientific Neuromodulation Corporation is voluntarily recalling Superion Indirect Decompression System devices due to potential weld breakage. The hazard may prevent proper device deployment during implantation.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: Superion Indirect Decompression System (IDS)
  • Model Numbers and Sizes: 101-9808 - 8mm, 01-9812 - 12mm, 101-9814 - 14mm
  • UPN/GTIN Codes: 00884662000529, 00884662000543, 00884662000550
  • Lot/Batch Numbers: 26176977, 26573432, 26375758, 26815560, 26807662, 26654632, 26928168, 26929605, 26489700, 26366842, 26848047, 26619510, 26323984, 26406210, 26799951
  • Distribution: U.S. Nationwide including AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MI, MN, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, WI, WV, and WY
  • Units Affected: 175 devices

The hazard

According to the FDA, the Superion Indirect Decompression System devices exhibit a potential for weld breakage at the spindle cap-to-main body interface. This separation may prevent proper deployment of the device during implantation.

Context

GovInfoNow's records show Boston Scientific Neuromodulation Corporation has had 12 other recalls on record since 2019-04-24. Recent recalls include the 2026-06-17 INFINION CX Lead Kits Recall for risk of lead fractures, the 2026-04-29 TCN Electrodes recall for not meeting performance levels, and the 2026-04-29 SC-4318 Clik X Anchor recall for lack of sterility assurance. Other recent recalls of similar products include the 2026-06-30 Rapid Refill System (risk of syringe disconnect), the 2026-07-09 ENROUTE Transcarotid Neuroprotection System (risk of arterial sheath tip separation), and the 2025-12-19 AXIOS Stent (deployment issues).

How to tell if you have this one

Check the model numbers and sizes listed: 101-9808 (8mm), 01-9812 (12mm), and 101-9814 (14mm). The specific lot/batch numbers are also listed in the recall notice for each model.

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

What to do — step by step

  1. Check Device Model

    Identify the model number and size from the device's label to confirm if it matches the recalled models: 101-9808 (8mm), 01-9812 (12mm), or 101-9814 (14mm).

  2. Contact Manufacturer

    Reach out to Boston Scientific directly for further instructions on the recall process or to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 33 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth 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: nationwideMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: 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: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: 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: “U.S Nationwide Distribution including states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MI, MN, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, WI, WV, and WY” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Mississippi, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 42 days after the firm started it.

1. Firm started the recall: Oct 12, 202212. FDA classified it Class II: Nov 13, 202223. Published in FDA’s Enforcement Report: Nov 23, 202232022
  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-0230-2023 (October 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0230-2023 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