Boston Scientific Neuromodulation Corporation
Valencia, CA
This page shows every FDA and USDA recall linked to Boston Scientific Neuromodulation Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
20
Total Recalls
2010
First Recall
2025
Most Recent
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Sep 12, 2025
· Device
Open, Classified
Superion IDS Kit
Superion Indirect Decompression System 8MM, VF Implant
101-9808
00884662000529
Superion Indi...
Sep 2, 2025
· Device
Open, Classified
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise...
Aug 19, 2025
· Device
Open, Classified
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Aug 14, 2024
· Device
Open, Classified
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and...
May 24, 2024
· Device
Open, Classified
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion I...
Jun 15, 2023
· Device
Open, Classified
Superion Indirect Decompression System (IDS)
Model Numbers and Size:
101-9808 - 8mm
01-9812 - 12mm
101-9814 -...
Nov 14, 2022
· Device
Open, Classified
Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioni...
Apr 10, 2020
· Device
Terminated
Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesio...
Apr 10, 2020
· Device
Terminated
Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesio...
Apr 10, 2020
· Device
Terminated
Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF...
Apr 10, 2020
· Device
Terminated
Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF...
Apr 10, 2020
· Device
Terminated
ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700.
2 x 8 Surgical Paddle Lead Kit: (1) On...
Apr 24, 2019
· Device
Terminated
Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimula...
Apr 24, 2019
· Device
Terminated
Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage:
Lead Extensions are d...
Apr 24, 2019
· Device
Terminated
Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cor...
Apr 24, 2019
· Device
Terminated
LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500.
Leads function as a component of Boston Sc...
Apr 24, 2019
· Device
Terminated
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350.
Package Contents:
Lead Extension Kit...
Apr 24, 2019
· Device
Terminated
The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation sys...
Apr 24, 2019
· Device
Terminated
Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
Apr 16, 2010
· Device
Terminated