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Infinion CX recallZ-2879-2026 · Boston Scientific Neuromodulation Corporation · initiated Jun 17, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Neuromodulation Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Device Design

What the company is doing

On 6/17/2026, removal notices were mailed and emailed to customers informing them of the following: 1) Stop further use or distribution and segregate affected product. 2) Complete and return the Reply Verification Tracking Form via email to [email protected] 3) Return affected devices to firm. 4) Share this communication with any healthcare professionals in your facility that use the product and with any other organization to which these systems may have been transferred. Report any adverse events or quality concerns associated with use of these devices to firm via email at [email protected] This removal of unused Infinion CX Leads is part of the planned transition to the next generation lead (Infinion Pro).

Recall details

Recall number
Z-2879-2026
Status
Open, Classified
Initiated by the company
Jun 17, 2026
Posted by the FDA
Aug 5, 2026
Recalling firm
Boston Scientific Neuromodulation Corporation
Quantity
1079
Product code
LGW
FDA submissions
P030017
Distribution
US: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina

Product description

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.

Code information (models, lots, serial numbers)

Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

92 devices cleared under P030017 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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