The Recall Desk

Manufacturer

Boston Scientific Neuromodulation Corporation

24 recalls in our database name Boston Scientific Neuromodulation Corporation as the manufacturing or recalling firm.

What the numbers show

Total
24
Critical
0
Severe
1
Most recent
2026-08-12

Of the 24 recalls from Boston Scientific Neuromodulation Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–24 of 24

  • SevereFDA (Devices)·Z-2879-2026·2026-08-12

    Boston Scientific Spinal Cord Stimulator Lead Kits Recalled

    Boston Scientific is recalling INFINION CX LEAD KITs (50cm and 70cm) used in spinal cord stimulator systems due to potential lead body stress at the anchor site, which may cause lead fractures or high impedance and result in inadequate stimulation or need for additional surgery.

    Product
    INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2694-2026·2026-07-15

    Intracept Access Instruments sterile barrier breach risk

    Boston Scientific is recalling Intracept Access Instruments due to potential sterile barrier breach in the outer tray seal, which could introduce infection risk.

    Product
    Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2404-2026·2026-06-17

    Boston Scientific Clik X anchors may lack sterility assurance

    Boston Scientific Clik X Anchors, model SC-4318, are being recalled because the sterile anchors may lack sterility assurance. 43 units are affected.

    Product
    Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2403-2026·2026-06-17

    Boston Scientific reusable TCN nitinol electrodes may underperform expected levels

    Boston Scientific TCN nitinol electrodes across four lengths are being recalled because the reusable electrodes may not meet expected performance levels. 49,251 units affected.

    Product
    Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2402-2026·2026-06-17

    Boston Scientific reusable CSK stainless steel electrodes may underperform expected levels

    Boston Scientific CSK stainless steel electrodes across several lengths are being recalled because the reusable electrodes may not meet expected performance levels. 31,923 units affected.

    Product
    Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2025·2025-09-24

    Deep brain stimulation implant manuals recalled after wire breaks in generators

    The Vercise Deep Brain Stimulation Systems Surgical Implant Manual is being recalled after wire breaks in rechargeable pulse generators implanted in the submuscular pectoral location. 25,260 units are affected.

    Product
    Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2485-2025·2025-09-10

    Spinal decompression implants recalled after review found instrument and device breakage

    Superion Indirect Decompression System implants and kits are recalled because a product performance review found the device and instruments are not consistently meeting expected performance, including breakage. 70,516 units are affected.

    Product
    Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2025·2025-08-27

    Deep brain stimulation burr hole kits recalled over retaining clip closing resistance

    Burr Hole Cover Kits used with the Vercise Deep Brain Stimulation System are recalled because resistance closing the retaining clip may cause procedural delay or lead migration requiring further surgery. 24,583 units are affected.

    Product
    Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2024·2024-08-21

    Spinal Cord Stimulation Devices May Reset During Charging, Causing Transient Therapy Loss

    Boston Scientific spinal cord stimulation implants may reset during routine charging, causing brief loss of therapy. Patients may experience undesired sensations when stimulation restarts, potentially leading to surgical intervention requests.

    Product
    WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2024·2024-06-05

    Vercise Genus Deep Brain Stimulation Device May Reset During Charging

    Boston Scientific is recalling Vercise Genus Deep Brain Stimulation devices that may reset during system checks while charging. The reset causes temporary loss of stimulation and may lead to symptom worsening.

    Product
    Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2023·2023-06-21

    Driver Instrument May Break During Surgery, Leaving Metal Fragments

    The Superion Indirect Decompression System's driver instrument may fracture during implantation if excessive force is applied, potentially leaving metal fragments in the surgical site. Retained fragments contraindicate MRI scans.

    Product
    Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0230-2023·2022-11-23

    Spinal Decompression System Recalled for Potential Weld Breakage

    Boston Scientific is recalling 175 Superion Indirect Decompression System devices due to potential weld breakage at the spindle cap that may prevent proper deployment during implantation.

    Product
    Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2124-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Lead Extensions Due to Labeling Error

    Boston Scientific is voluntarily removing 41 units of spinal cord stimulation lead extensions because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the le
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2119-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error

    Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1) M
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2121-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error

    Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    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) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inh
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2122-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error

    Boston Scientific is voluntarily removing certain spinal cord stimulation leads and extensions because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    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 in the management of chronic intractable pain of the trunk and/or limbs. Package Contents Percutaneous Permanent Lead Kits (
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2123-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Adapters Due to Labeling Error

    Boston Scientific is voluntarily removing two Precision M8 Adapters because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilater
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2120-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Extension Kits Due to Labeling Error

    Boston Scientific is voluntarily removing 19 units of 35 cm 8 Contact Extension Kits because the 'use by date' on the label is later than the correct date.

    Product
    Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2125-2020·2020-06-03

    Boston Scientific Recalls Deep Brain Stimulation Lead Extensions Due to Labeling Error

    Boston Scientific is voluntarily removing specific Deep Brain Stimulation lead extensions because the 'use by date' on the label is later than the correct date.

    Product
    Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1696-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily recalling 118 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1697-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 40 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1698-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 43 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1694-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 437 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1695-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily recalling 110 Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Boston Scientific Neuromodulation Corporation

Parent company
Boston Scientific

Source: Wikidata (Q125304933), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.