DeviceSignal · Recall classified
Boston Scientific Neuromodulation Corporation
FDA classified a device recall on 2026-08-05 · Class I · Z-2879-2026
EventRecall classified
Effective2026-08-05
ClassificationClass I
On 2026-08-05 the FDA classified a device recall from Boston Scientific Neuromodulation Corporation as Class I. Product: INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX…. Recall Z-2879-2026. The firm initiated it on 2026-06-17. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2879-2026
- Classification
- Class I
- Classified on
- 2026-08-05
- Initiated on
- 2026-06-17
- Firm
- Boston Scientific Neuromodulation Corporation
- Reason
- 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.
- 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.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2879-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
2ead78dbd169238ac55e72ded77d6af5a1e4da2f1c8c79282010861808f16b63- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)