Home / Recalls / Boston Scientific Neuromodulation Corporation / Z-2340-2025

Z-2340-2025 Class II Ongoing

Recalled by Boston Scientific Neuromodulation Corporation — Valencia, CA

Recall Details

Product Type
Devices
Report Date
August 27, 2025
Initiation Date
July 8, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24,583

Product Description

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

Reason for Recall

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 delay, or lead-migration-which may require additional surgery.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of MN, FL, CO, MD, NY, NE, PA, WI, AZ, TN, MO, TX, MI, MT, MA, WV, AL, VA, NC, CA, OR, WA, LA, OH, NJ, NH, SD, GA, CT, NV, UT, IN, ID, IL, ME, SC, DC, OK, KY, AK, HI, RI, AR, KS, NM and the countries of Algeria, Austria, Azerbaijan, Belgium, Bulgaria, Croatia, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, T¿rkiye, UAE, Ukraine, United Kingdom, Canada, Japan, Argentina, Brazil, Chile, Colombia , Ecuador, Mexico, Hong Kong, China, India, Singapore, Korea, Taiwan.

Code Information

All lots. Surgical Implant Manual version REF/UDI-DI: M365DB4600C0/08714729820802, M365DB4605C0/08714729820819

Other recalls by Boston Scientific Neuromodulation Corporation

  • Z-2558-2025 Class II — Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: (July 8, 2025)
  • Z-2485-2025 Class II — Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-98 (June 6, 2025)
  • Z-2617-2024 Class II — WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, (July 17, 2024)
  • Z-1890-2024 Class II — Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 (April 18, 2024)
  • Z-1972-2023 Class II — Driver Instrument, part of the Superion Indirect Decompression System, REF: 102- (May 12, 2023)
  • Z-0230-2023 Class II — Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-98 (October 12, 2022)
  • Z-1698-2020 Class II — Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is indica (May 30, 2019)
  • Z-1695-2020 Class II — Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electro (May 30, 2019)
  • Z-1697-2020 Class II — Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Electro (May 30, 2019)
  • Z-1696-2020 Class II — Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is indi (May 30, 2019)