Official recall record
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC231
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-06-17
- Country of alert
- United States
- Alert level
- Class I
- Alert type
- recall
- Barcode (EAN/GTIN)
- 08714729861614
- Brand on record
- Boston Scientific Neuromodulation Corporation
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
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Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise - 2025-07-08 · US FDA — Medical Devices
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
All 5 official recall notices naming Boston Scientific Neuromodulation Corporation on this site →
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