Drugs & medicalClass II

Boston Scientific Neuromodulation Corporation recalls Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep…

Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural…

Read the official notice →
Date
2025-08-27
Country
United States
Brand
Boston Scientific Neuromodulation
Product
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used…
Classification
Class II
Units
Worldwide - US Nationwide distribution including in the states of MN, FL, CO,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Boston Scientific Neuromodulation recalls

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    Boston Scientific Neuromodulation Corporation recalls Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF:…

    Reusable electrodes may not meet expected performance levels.

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  3. 2025-09-24
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    Boston Scientific Neuromodulation Corporation recalls Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

    Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device…

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  5. 2025-09-10
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    Boston Scientific Neuromodulation Corporation recalls Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect…

    As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and…

    FDA · DeviceBoston Scientific Neuromodulation CorporationU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice →
  7. 2024-08-21
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    Boston Scientific Neuromodulation Corporation recalls WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320

    Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may…

    FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide Distribution: US (nationwide) including states of: TN, PA, WA, SC,…Official notice →
  9. 2024-06-05
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    Boston Scientific Neuromodulation Corporation recalls Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32…

    Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients…

    FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide - US Nationwide distribution including in the states of TX, WA, MT,…Official notice →
  11. 2023-06-21
  12. US
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    Boston Scientific Neuromodulation Corporation recalls Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion…

    Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver…

    FDA · DeviceBoston Scientific Neuromodulation CorporationUS Nationwide Distribution: IN, NY, IL, PA, FL, SC, TX, MA, VA, AL, WI, OK,…Official notice →
All 11 Boston Scientific Neuromodulation recalls →

Other drugs & medical recalls in the United States

  1. 2025-09-03
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    Dynex Technologies, Inc. recalls Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility…

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