Class 2 Device Recall Vercise Deep Brain Stimulation Systems Surgical Implant Manual

• Date Initiated by Firm: July 08, 2025
• Date Posted: September 12, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2558-2025
• Recall Event ID: 97144
• PMA Number: P150031
• Product Classification: Stimulator, electrical, implanted, for parkinsonian symptoms - Product Code NHL
• Product: Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
• Code Information: UDI-DI: 08714729985044, 08714729985051. Document Number/Revision: 92328632-09, Rev A
• Recalling Firm/ Manufacturer: Boston Scientific Neuromodulation Corporation; 25155 Rye Canyon Loop; Valencia CA 91355-5004
• For Additional Information Contact: Renee Archie; 508-683-4523
• Manufacturer 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.
• FDA Determined Cause: Labeling design
• Action: 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
• Quantity in Commerce: 25,260
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NHL