Boston Scientific Neuromodulation Corporation: Device Recall

Recall Details

Recall Number

Z-2558-2025

Classification

Class II

Product Type

Device

Recalling Firm

Boston Scientific Neuromodulation Corporation

Status

Ongoing

Date Initiated

07/08/2025

Location

Valencia, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

25,260

Reason for Recall

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 removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

Product Description

Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

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 Argentina, Brazil, Chile, Ecuador, Colombia , Mexico, Canada, Japan, 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, Turkiye, UAE, Ukraine, United Kingdom, Hong Kong, China, Singapore, Korea, Taiwan , India, Thailand.

Other Recalls by Boston Scientific Neuromodulation Corporation

• Class II: Risk 07/08/2025
  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.
• Class II: Risk 06/06/2025
  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 implant/device.
• Class II: Risk 07/17/2024
  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 experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.
• Class II: Risk 04/18/2024
  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 may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

View all recalls by Boston Scientific Neuromodulation Corporation →