Boston Scientific Neuromodulation Corporation
12 recalls on record · Latest: Sep 24, 2025
FDA Devices Moderate Sep 24, 2025
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
FDA Devices Moderate Sep 10, 2025
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF…
FDA Devices Moderate Aug 27, 2025
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the S…
FDA Devices Moderate Aug 21, 2024
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
FDA Devices Moderate Jun 21, 2023
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Super…
FDA Devices Moderate Jun 3, 2020
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (…
FDA Devices Moderate Jun 3, 2020
LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS…
FDA Devices Moderate Jun 3, 2020
Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use …
FDA Devices Moderate Jun 3, 2020
Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous lea…
FDA Devices Moderate Jun 3, 2020
Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription u…
FDA Devices Moderate Jun 3, 2020
The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid…
FDA Devices Moderate Apr 22, 2020