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Lower risk Medical device recall · FDA · Published April 24, 2019

Boston Scientific 35cm Spinal Cord Stimulation Kit Recall: Incorrect Use By Date

Boston Scientific recalls 35cm spinal cord stimulation extension kits with incorrect use by dates. No health risks expected from this labeling error.

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

🇺🇸 FDA recall #Z-2120-2020Medical deviceBoston Scientific ›
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Recalling firmBoston Scientific Neuromodulation Corporation25155 Rye Canyon Loop · Valencia, CA 91355-5004
✎ GovInfoNow plain-language explainer

Boston Scientific is recalling 35cm spinal cord stimulation extension kits that have an incorrect 'use by date' label. This labeling error means the product might be used beyond its intended shelf life, but no health risks are expected. Read more at govinfonow.com/recall/68026-boston-scientific-35cm-spinal-cord-stimulation-kit-recall-incorrect-use.

Source Summary by GovInfoNow · govinfonow.com/recall/68026-boston-scientific-35cm-spinal-cord-stimulation-kit-recall-incorrect-use · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2120-2020

Cite this page

“Boston Scientific 35cm Spinal Cord Stimulation Kit Recall: Incorrect Use By Date.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68026-boston-scientific-35cm-spinal-cord-stimulation-kit-recall-incorrect-use. Based on FDA recall #Z-2120-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2120-2020%22&limit=1).

The FDA announced on April 24, 2019, that Boston Scientific Neuromodulation Corporation is recalling Thirty-five (35) cm 8 Contact Extension Kits due to incorrect 'use by' dates on labels. The agency stated no adverse health consequences are expected from this issue.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350
  • Serial numbers: 1041034, 1055172, 3000549, 1041380, 1056806, 3000564, 1053375, 1058008, 3001907, 1053695, 1058015, 3007457, 1053700, 1058017, 3008119, 1054299, 1062660, 1054304, and 1064590
  • Distribution: Distributed OUS only to 14 countries

The hazard

The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date." No adverse health consequence is expected to occur from this issue.

Context

GovInfoNow's records show Boston Scientific Neuromodulation Corporation has 12 other recalls on record since May 30, 2019. Other recent recalls of similar products include Boston Scientific INFINION CX Lead Kits Recall (June 17, 2026), Boston Scientific CSK Electrodes Recall (April 29, 2026), and Boston Scientific SC-4318 Clik X Anchor Recall (April 29, 2026). Other recent recalls of similar products include Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation (May 13, 2026), Medtronic Pocket Adaptor Kits with Incorrect Use-By Dates Recalled (May 13, 2026), and Inspire Stimulation Lead Recall (May 11, 2026).

How to tell if you have this one

Check for part number M365SC3138350 on the kit. The affected kits have specific serial numbers including 1041034, 1055172, and others listed in the recall notice.

  • Brand
    Boston Scientific
  • Category
    Medical device
FDA recall event · 7 products

All 7 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
    Distributed OUS only. to 14 countries.
Recall numberProduct, codes & lotsQuantity
Z-2119-2020ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1) Manual - Product Usage: The surgical paddle leads function as a component of Boston Scientific s spinal cord stimulator (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in a inhibition of pain sensation.; Part number M365SC8216700; serial numbers 632107 and 6456082 units
Z-2120-2020Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact extension kits are part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. They are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation.; Part number M365SC3138350; serial numbers 1041034, 1055172, 3000549, 1041380, 1056806, 3000564, 1053375, 1058008, 3001907, 1053695, 1058015, 3007457, 1053700, 1058017, 3008119, 1054299, 1062660, 1054304, and 1064590.19 units
Z-2121-2020LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation. Package Contents Percutaneous Permanent Lead Kits (1) Percutaneous Lead with pre-loaded Curved Stylet (1) Stylet Ring with a Curved and a Straight Stylet (4) Suture Sleeves (1) Insertion Needle with Stylet (1) Lead Blank (1) Steering Cap (1) OR Cable Assembly (2) Lead Position Labels left and right (non-sterile) (1) Device Registration Form/Temporary Patient Identification Card (1) Manual; Part number M365SC2352500; serial numbers 1039736, 1039779, and 1042340.3 units
Z-2122-2020The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. Package Contents Percutaneous Permanent Lead Kits (1) Percutaneous Lead with pre-loaded Curved Stylet (1) Stylet Ring with a Curved and a Straight Stylet (4) Suture Sleeves (1) Insertion Needle with Stylet (1) Lead Blank (1) Steering Cap (1) OR Cable Assembly (2) Lead Position Labelsleft and right (non-sterile) (1) Device Registration Form/Temporary Patient Identification Card (1) Manual; Part number M365SC2352700; serial number 1042757.1 unit
Z-2123-2020Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.; Part number M365SC9218150; serial numbers 1043743 and 1051329.2 units
Z-2124-2020Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual; Part number M365SC3138550; serial numbers 1044463, 1066242, 3003060, 1044464, 1068589, 3006620, 1044466, 1068602, 3009041, 1061554, 1068606, 3009045, 1062766, 1068608, 3009050, 1062770, 1068611, 3010114, 1062787, 3001046, 3012781, 1063430, 3002547, 3013204, 1063632, 3002561, 3013267, 1063650, 3002817, 3018105, 1063749, 3003040, 3018106, 1063798, 3003042, 3018866, 1063801, 3003047, 3036973, 1066182, and 3003048.41 units
Z-2125-2020Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson s disease (PD) that are not adequately controlled with medication.; Part number M365NM3138550; serial numbers 1049357, 1057232, 3014616, 1053194, 3010769, 3014631, 1057225 and 3012324.8 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the part number and serial numbers listed in the recall notice to confirm if your kit is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Apr 24, 201912. FDA classified it Class II: May 26, 202023. Published in FDA’s Enforcement Report: Jun 3, 202034. FDA terminated the recall: Jan 18, 2022420192022
  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.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this kit?

Check the part number and serial numbers listed in the recall notice to see if your kit is affected. If it is, you don't need to take any action beyond checking.

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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-2120-2020 (April 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2120-2020 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