Z-1890-2024Class II

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

Name: Z-1890-2024 Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160...
Creator: Boston Scientific Neuromodulation Corporation
Published: 2024-04-18
License: https://open.fda.gov/license/

Boston Scientific Neuromodulation Corporation / initiated 2024-04-18 / Open, Classified / root cause: design

FDA source

Boston Scientific Neuromodulation Corporation began a recall of Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320 on 2024-04-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1890-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-18
Posted: 2024-05-24
Recalling firm: Boston Scientific Neuromodulation Corporation
Product: Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
Product code: NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 4/18/24, correction notices were mailed to Physicians/Surgeons, Hospitals, Healthcare Professionals who were asked to do the following: 1) Review any patient reports of undesired sensations indicative of potential device reset behavior during IPG charging and report these observations accordingly to the firm. 2) After firm verifies this device reset behavior has occurred during IPG charging, an in-field IPG firmware update can be scheduled for the patient s device. This will eliminate the possibility of a coincident routine device system check during IPG charging, thus preventing a potential system reset. Any adverse events or quality concerns associated with use of this product should be reported to firm via email [email protected]
Quantity in commerce: 14,977
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1890-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1890-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-24

Product code NHL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)