Z-2879-2026Class I

INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model...

Name: Z-2879-2026 INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model...
Creator: Boston Scientific Neuromodulation Corporation
Published: 2026-06-17
License: https://open.fda.gov/license/

Boston Scientific Neuromodulation Corporation / initiated 2026-06-17 / Open, Classified / root cause: design

FDA source

Boston Scientific Neuromodulation Corporation began a recall of 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... on 2026-06-17. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2879-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-06-17
Posted: 2026-08-05
Recalling firm: Boston Scientific Neuromodulation Corporation
Product: 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.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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).
Quantity in commerce: 1079
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 codes and lots: Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2879-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2879-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)