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Boston Scientific Neuromodulation Corporation FDA Recalls
12 recalls on file across devices, 1 of them Class I and 12 still open. Matched by name to BSX.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70,Class IJun 17, 2026Spinal cord stimulation system lead body may be exposed to s |
| Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180Class IIApr 29, 2026Sterile anchors my lack sterility assurance. |
| Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN ElecClass IIApr 29, 2026Reusable electrodes may not meet expected performance levels |
| Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10Class IIApr 29, 2026Reusable electrodes may not meet expected performance levels |
| Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENClass IIApr 22, 2026Intraosseous nerve ablation system instruments may have ster |
| Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep StimuClass IIJul 8, 2025Resistance and difficulties could occur while closing the re |
| Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09Class IIJul 8, 2025Wire break(s) have occurred in rechargeable deep brain stimu |
| Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Class IIJun 6, 2025As a result of a comprehensive product performance review it |
| WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320Class IIJul 17, 2024Spinal Cord Stimulation (SCS) Implantable Pulse Generator (I |
| Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KClass IIApr 18, 2024Deep Brain Stimulation (DBS) Implantable Pulse Generator (IP |
| Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect DeClass IIMay 12, 2023Pending update to indirect decompression system instructions |
| Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mClass IIOct 12, 2022Due to Indirect Decompression System devices exhibiting a po |