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All Recalls

Every Boston Scientific Neuromodulation Corporation Recall

Sorted by most recent. Click any recall for full details.

11 recalls
High RiskFDA
Boston Scientific Neuromodulation Corporation
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System use...
Medical Implants·24,583 affected·Jul 8, 2025
High RiskFDA
Boston Scientific Neuromodulation Corporation
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Medical Implants·25,260 affected·Jul 8, 2025
High RiskFDA
Boston Scientific Neuromodulation Corporation
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression Sys...
Medical Implants·70,516 affected·Jun 6, 2025
High RiskFDA
Boston Scientific Neuromodulation Corporation
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Medical Devices·77,674 affected·Jul 17, 2024
High RiskFDA
Boston Scientific Neuromodulation Corporation
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression Syste...
Surgical Devices·21,533 affected·May 12, 2023
High RiskFDA
Boston Scientific Neuromodulation Corporation
Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tiss...
Medical Devices·43 affected·May 30, 2019
High RiskFDA
Boston Scientific Neuromodulation Corporation
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) H...
Medical Implants·19 affected·Apr 24, 2019
High RiskFDA
Boston Scientific Neuromodulation Corporation
LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stim...
Medical Devices·3 affected·Apr 24, 2019
High RiskFDA
Boston Scientific Neuromodulation Corporation
Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indica...
Medical Devices·8 affected·Apr 24, 2019
High RiskFDA
Boston Scientific Neuromodulation Corporation
Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the perc...
Medical Implants·41 affected·Apr 24, 2019
High RiskFDA
Boston Scientific Neuromodulation Corporation
Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for pr...
Medical Devices·2 affected·Apr 24, 2019