Boston Scientific Neuromodulation Corporation

Complete recall history across all FDA and CPSC categories — 19 total recalls

Boston Scientific Neuromodulation Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (19)

FDA medical device enforcement actions by Boston Scientific Neuromodulation Corporation

Date Product Reason Class
Jul 8, 2025 Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Numb... Wire break(s) have occurred in rechargeable deep brain stimulation implantabl... Class II
Jul 8, 2025 Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M36... Resistance and difficulties could occur while closing the retaining clip lock... Class II
Jun 6, 2025 Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101... As a result of a comprehensive product performance review it was determine th... Class II
Jul 17, 2024 WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-123... Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experienc... Class II
Apr 18, 2024 Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R... Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience... Class II
May 12, 2023 Driver Instrument, part of the Superion Indirect Decompression System, REF: 1... Pending update to indirect decompression system instructions for use informin... Class II
Oct 12, 2022 Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101... Due to Indirect Decompression System devices exhibiting a potential for weld ... Class II
May 30, 2019 Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is i... The firm initiated a voluntary correction of certain Cosman TCN Electrodes du... Class II
May 30, 2019 Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Elec... The firm initiated a voluntary correction of certain Cosman TCN Electrodes du... Class II
May 30, 2019 Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Elec... The firm initiated a voluntary correction of certain Cosman TCN Electrodes du... Class II
May 30, 2019 Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is i... The firm initiated a voluntary correction of certain Cosman TCN Electrodes du... Class II
May 30, 2019 Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is ind... The firm initiated a voluntary correction of certain Cosman TCN Electrodes du... Class II
Apr 24, 2019 ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8... The firm is initiating a voluntary removal of certain spinal cord stimulation... Class II
Apr 24, 2019 The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part... The firm is initiating a voluntary removal of certain spinal cord stimulation... Class II
Apr 24, 2019 Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: Th... The firm is initiating a voluntary removal of certain spinal cord stimulation... Class II
Apr 24, 2019 Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Produ... The firm is initiating a voluntary removal of certain spinal cord stimulation... Class II
Apr 24, 2019 Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Prod... The firm is initiating a voluntary removal of certain spinal cord stimulation... Class II
Apr 24, 2019 LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads fun... The firm is initiating a voluntary removal of certain spinal cord stimulation... Class II
Apr 24, 2019 Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Pack... The firm is initiating a voluntary removal of certain spinal cord stimulation... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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