Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
- Recall Initiated
- July 8, 2025
- Posted
- September 12, 2025
- Recall Number
- Z-2558-2025
- Quantity
- 25,260
- Firm Location
- Valencia, CA
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.
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.
Lot / Code Info
UDI-DI: 08714729985044, 08714729985051. Document Number/Revision: 92328632-09, Rev A
Root Cause
Labeling design
Action Taken
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