Boston Scientific Neuromodulation Corporation: Medical Device Recall in 2024 - (Recall #: Z-1890-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320

Product Classification:

Class II

Date Initiated: April 18, 2024

Date Posted: June 5, 2024

Recall Number: Z-1890-2024

Event ID: 94377

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 14,977

Code Information:

REF/UDI-DI(GTIN)/Serial Number Range/Expiration Date Range: M365DB12160/8714729985044/100209 - 753347/09-OCT-2020 through 26-MAR-2026; M365DB12320/8714729985051/100104 - 753200/09-OCT-2020 through 21-MAR-2026

Distribution Pattern:

Worldwide - US Nationwide distribution including in the states of TX, WA, MT, GA, TN, MA, OR, ID, CA, FL, WI, UT, DE, AZ, PA, DC, LA, KY, VA, MN, NC, OH, NY, MI, CO, IN, MD, NV, AL, IL, AR, SC, OK, MO, MS, NJ, ME, Hi, KS, SD, WV, NM, AK, CT, WY, NE, ND and the countries of Canada, Argentina, Chile, Colombia, Brazil, Algeria, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Italy, Jordan, Kazakhstan, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, Australia, Thailand, Singapore, Hong Kong, Korea, India, Japan.

Voluntary or Mandated:

Voluntary: Firm initiated