Class I U.S. Food and Drug Administration

Boston Scientific Neuromodulation Corporation Infinion CX Lead KIT, 50CM recall: Spinal cord stimulation system lead body may be exposed to stress

Recall published 2 months ago

Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2879-2026
Published
August 12, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Boston Scientific Neuromodulation Corporation
Product type
Medical devices
Units affected
1079
Distribution
New York
Made in
United States
Lot / code info
Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
UPC codes
08714729861614

Products covered by this recall

INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 08714729861614

Model or item number

On the rating label, the box or the instruction sheet.

  • SC-2317-50
  • SC-2317-70
  • s. — 1079

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Boston Scientific Neuromodulation Corporation — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Boston Scientific Neuromodulation Corporation — 25155 Rye Canyon Loop, Valencia, CA, 91355-5004

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Boston Scientific Neuromodulation Corporation medical… recalled?

Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement. Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 08714729861614; model number SC-2317-50, SC-2317-70, s. — 1079. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Which states were affected?

The notice lists New York.

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