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Lower risk Medical device recall · FDA · Published May 30, 2019

Boston Scientific Nitinol Thermocouple Electrode Recall: Incorrect Instructions for Use

Boston Scientific recalls certain Nitinol Thermocouple Electrodes (5cm) due to incorrect Instructions for Use packaging. This may lead to improper use of the device for nerve pain treatment.

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

🇺🇸 FDA recall #Z-1698-2020Medical 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 Nitinol Therm: 5cm electrodes because the packaging includes incorrect instructions for use. This could lead to improper application during nerve pain treatment procedures. Read more at govinfonow.com/recall/67821-boston-scientific-nitinol-thermocouple-electrode-recall-incorrect-instructions-for-use.

Source Summary by GovInfoNow · govinfonow.com/recall/67821-boston-scientific-nitinol-thermocouple-electrode-recall-incorrect-instructions-for-use · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1698-2020

Cite this page

“Boston Scientific Nitinol Thermocouple Electrode Recall: Incorrect Instructions for Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67821-boston-scientific-nitinol-thermocouple-electrode-recall-incorrect-instructions-for-use. Based on FDA recall #Z-1698-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1698-2020%22&limit=1).

Boston Scientific Neuromodulation Corporation recalled Nitinol Thermocouple Electrodes due to incorrect Instructions for Use being packaged with the products, according to the FDA on May 30, 2019.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: Nitinol Thermocouple Electrode, 5cm
  • UPC: 00813250013047
  • Lot Numbers: 23263846 and 23263848

The hazard

The firm initiated a voluntary correction of certain Cosman TCN Electrodes because the Instructions for Use packaged with these products contained an incorrect 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 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 FARASTAR Ablation Generator Recall (June 11, 2026), the Medline Convenience Kits: Temperature Probe Recall Due to Distribution Error (May 28, 2026), and the Boston Scientific FARASTAR Ablation Generator EU Recall (June 11, 2026).

How to tell if you have this one

Check for Lot Numbers 23263846 or 23263848 on the packaging. The product is a 5cm Nitinol Thermocouple Electrode used for RF heat lesioning of nerve tissue.

  • Brand
    Boston Scientific
  • Product
    Nitinol Thermocouple Electrode, 5cm
  • Category
    Medical device
FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide distribution in the states of AZ, CA,CO, FL,GA, ID,IL, IN, KY, MA, MD, MI, MO, NV, NY, OH, OK, OR, SC, TX, UT, VA, WA, and WI.
Recall numberProduct, codes & lotsQuantity
Z-1694-2020Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.; TCN-10, GTIN:00813250013054, Lot Numbers: 23045871, 23049691, 23049693, 23049695, 23131523, 23131525, 23155050, 23155052, 23176308, 23213325, 23213326, 23235460, and 23235463.437 units
Z-1695-2020Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.; TCN-10-3M; GTIN: 00813250017502; Lot Numbers: 23049683, 23239528, and 23239529.110 units
Z-1696-2020Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.; TCN-15; GTIN:00813250013061; Lot Numbers: 23014533, 23049687, 23049688, and 23192881.118 units
Z-1697-2020Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.; TCN-15-3M; GTIN: 00813250017519; Lot Number:2304968440 units
Z-1698-2020Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.; Nitinol Thermocouple Electrode, 5 cm; GTIN:00813250013047; Lot Numbers: 23263846 and 23263848.43 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for Lot Numbers 23263846 or 23263848 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 24 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: 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: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AZ, CA,CO, FL,GA, ID,IL, IN, KY, MA, MD, MI, MO, NV, NY, OH, OK, OR, SC, TX, UT, VA, WA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Michigan, Missouri, Nevada, New York, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: May 30, 201912. FDA classified it Class II: Apr 10, 202023. Published in FDA’s Enforcement Report: Apr 22, 202034. FDA terminated the recall: Apr 28, 2021420192021
  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.

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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-1698-2020 (May 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1698-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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