Urgent site urgencyFDA Class I

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

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.

Agency
FDA Device
Recall date
Jun 17, 2026
Status
Ongoing
Company
Boston Scientific Neuromodulation Corporation

1. What product was recalled?

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

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.

Quantity: 1079

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

LOT
Model/UDI-DI: SC-2317-50/08714729861614
LOT
SC-2317-70/08714729861638. All unused products.
RECALL-NUMBER
Z-2879-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

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.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

New York

View source evidence for state distribution
  • New York: 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

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Device source

The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.