Boston Scientific Neuromodulation Corporation

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
1
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2340-2025Class IIBurr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components oJuly 8, 2025
Z-2558-2025Class IIVercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09July 8, 2025
Z-2485-2025Class IISuperion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 June 6, 2025
Z-2617-2024Class IIWAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M36July 17, 2024
Z-1890-2024Class IIVercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DBApril 18, 2024
Z-1972-2023Class IIDriver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the May 12, 2023
Z-0230-2023Class IISuperion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - October 12, 2022
Z-1698-2020Class IINitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heMay 30, 2019
Z-1695-2020Class IINitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for May 30, 2019
Z-1697-2020Class IINitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for May 30, 2019
Z-1696-2020Class IINitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF May 30, 2019
Z-1694-2020Class IINitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF May 30, 2019
Z-2120-2020Class IIThirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead ExtApril 24, 2019
Z-2124-2020Class IIFifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead ExtensApril 24, 2019
Z-2122-2020Class IIThe LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimuApril 24, 2019
Z-2119-2020Class IIArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead KApril 24, 2019
Z-2123-2020Class IIPrecision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a April 24, 2019
Z-2121-2020Class IILinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component ofApril 24, 2019
Z-2125-2020Class IIFifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep BraApril 24, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 August 7, 2025