Boston Scientific Neuromodulation Corporation recalls
Every recall we track for Boston Scientific Neuromodulation Corporation — 24 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Boston Scientific Neuromodulation Corporation peaked in 2019 (12); 24 since 2017.
All FDA recall records for Boston Scientific Neuromodulation Corporation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 12 | 0 | 12 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 1 | 0 | 0 | 1 |
| 2023 | 0 | 1 | 0 | 0 | 1 |
| 2024 | 0 | 2 | 0 | 0 | 2 |
| 2025 | 0 | 2 | 1 | 0 | 3 |
| 2026 (to date) | 0 | 1 | 3 | 1 | 5 |
Most common reasons for Boston Scientific Neuromodulation Corporation recalls
What to do if you have a recalled Boston Scientific Neuromodulation Corporation product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Boston Scientific Neuromodulation Corporation recalls
13 shown- Use cautionMedical device
Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70,
Boston Scientific recalls INFINION CX lead kits (50cm and 70cm models) due to potential lead fractures causing inadequate spinal stimulation. Affected users should contact for repair or replacement.
Boston ScientificJun 17, 2026 - UnratedMedical device
Boston Scientific Neuromodulation Corporation recalls Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Boston Scientific recalls SC-4318 Clik X Anchor due to sterile anchors lacking sterility assurance. Affected units have specific model and lot numbers. Consumers should contact the company for details.
Boston ScientificApr 29, 2026 - Lower riskMedical device
Boston Scientific Neuromodulation Corporation recalls Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF:
Boston Scientific recalls CSK Electrodes with specific model numbers due to potential performance issues. Affected units may not function as intended, but no injuries reported. Consumers should check model details and contact for guidance.
Boston ScientificApr 29, 2026 - Lower riskMedical device
Boston Scientific Neuromodulation Corporation recalls Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS
Boston Scientific recalls Intracept Access Instruments (RLV0035, RLV0045, RLV0055, RLV0065, RLV0075) due to potential sterile barrier breach in the outer tray seal, which could lead to severe infection. Affected units have specific lot numbers and expiration dates.
Boston ScientificApr 22, 2026 - Use cautionMedical device
Boston Scientific Neuromodulation Corporation recalls Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Boston Scientific recalls Vercise Deep Brain Stimulation Systems with wire breaks that prevent proper function, risking loss of therapy and symptoms return. Affected units have specific UDI-DI numbers.
Boston ScientificJul 8, 2025 - Use cautionMedical device
Boston Scientific Neuromodulation Corporation recalls Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep
Boston Scientific recalls Burr Hole Cover Kits (REF: M365DB4600C0 and M365DB4605C0) for potential procedure delays or additional surgery due to locking mechanism issues in Deep Brain Stimulation systems.
Boston ScientificJul 8, 2025 - Lower riskMedical device
Boston Scientific Neuromodulation Corporation recalls Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect
Boston Scientific recalls Superion Indirect Decompression System kits (8mm-16mm) due to inconsistent performance, including breakage of instruments and implants. Affected units have specific lot/batch numbers listed in the recall notice.
Boston ScientificJun 6, 2025 - Use cautionMedical device
Boston Scientific Neuromodulation Corporation recalls WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Boston Scientific recalls WAVEWRITER ALPHA spinal cord stimulation devices with specific model numbers due to potential temporary loss of therapy causing discomfort and possible surgical intervention requests. Affected units have unique reference codes and serial numbers.
Boston ScientificJul 17, 2024 - Use cautionMedical device
Boston Scientific Neuromodulation Corporation recalls Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG
Boston Scientific recalls Vercise Genus Deep Brain Stimulation implantable pulse generators with specific model numbers due to potential device reset during charging, which may cause temporary loss of stimulation and worsened symptoms.
Boston ScientificApr 18, 2024 - Use cautionMedical device
Boston Scientific Neuromodulation Corporation recalls Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect
Boston Scientific recalls Driver Instrument (REF: 102-9800) used in Superion Indirect Decompression System. Excessive force during implant may cause tip breaks, leading to metal fragments that could cause injury if not removed. MRI scans are unsafe if fragments remain.
Boston ScientificMay 12, 2023 - Use cautionMedical device
Boston Scientific Neuromodulation Corporation recalls Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
Boston Scientific recalls Superion Indirect Decompression System models 101-9808, 01-9812, and 101-9814 due to potential spindle cap weld breakage that may prevent proper device deployment during surgery.
Boston ScientificOct 12, 2022 - Lower riskMedical device
Boston Scientific Neuromodulation Corporation recalls Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of
Boston Scientific recalls certain Nitinol Thermocouple Electrodes (5cm) due to incorrect Instructions for Use packaging. This may lead to improper use of the device for nerve pain treatment.
Boston ScientificMay 30, 2019 - Lower riskMedical device
Boston Scientific Neuromodulation Corporation recalls Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead
Boston Scientific recalls 35cm spinal cord stimulation extension kits with incorrect use by dates. No health risks expected from this labeling error.
Boston ScientificApr 24, 2019
Boston Scientific Neuromodulation Corporation recall questions
How many recalls has Boston Scientific Neuromodulation Corporation had?
24 recalls from Boston Scientific Neuromodulation Corporation are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Boston Scientific Neuromodulation Corporation recall?
Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70,, dated Jun 17, 2026. Every Boston Scientific Neuromodulation Corporation recall is listed on this page, newest first.
Why are Boston Scientific Neuromodulation Corporation products recalled?
The most common reasons on record: Reusable electrodes may not meet expected performance levels. (2).
What should I do if I have a recalled Boston Scientific Neuromodulation Corporation product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Boston Scientific Neuromodulation Corporation recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.