Vercise Brain Stimulation System (Boston Scientific) – Wire Break Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Brand
Boston Scientific Neuromodulation Corporation
Lot Codes / Batch Numbers
UDI-DI: 08714729985044, 08714729985051. Document Number/Revision: 92328632-09, Rev A
Products Sold
UDI-DI: 08714729985044, 08714729985051. Document Number/Revision: 92328632-09, Rev A
Boston Scientific Neuromodulation Corporation is recalling Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 due to Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 7/8/2025, correction notices were mailed in the U.S. and mailed, emailed, or hand delivered outside the U.S. Healthcare Professionals were asked to do the following: 1) Review the Surgical Implant Manual updates. 2) If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. 3) A patient letter is enclosed with this communication, which can be shared with your patient and/or included within the patient's medical record. 4) Monitor per relevant IFU recommendations for any clinical observations of high monopolar impedances, undesired sensation, sudden loss of therapy, return of pre-implant symptoms and/or Bluetooth connectivity challenges, as these may be signals of potential feedthrough wire break(s) (component damage). 5) If you are a distributor, this notification must be forwarded to your customers to ensure this notification is carried out to the end-user level. 6) To provide awareness of this information, share this letter with any other clinicians in your hospital who use the system. 7) Maintain a copy of this letter in your facility's records. 8) Complete and return the acknowledgement form via email to BSCFieldActionCenter@bsci.com report all device-related incidents or quality concerns experienced with the use of these devices to the firm at BSN.ComplaintCallCenter@bsci.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026