Z-2558-2025Class II

Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

Name: Z-2558-2025 Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Creator: Boston Scientific Neuromodulation Corporation
Published: 2025-07-08
License: https://open.fda.gov/license/

Boston Scientific Neuromodulation Corporation / initiated 2025-07-08 / Open, Classified / root cause: labeling and UDI

FDA source

Boston Scientific Neuromodulation Corporation began a recall of Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 on 2025-07-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2558-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-08
Posted: 2025-09-12
Recalling firm: Boston Scientific Neuromodulation Corporation
Product: Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Product code: NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
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.
Root cause tag: labeling and UDI
FDA root 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 [email protected] report all device-related incidents or quality concerns experienced with the use of these devices to the firm at [email protected]
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.
Product codes and lots: UDI-DI: 08714729985044, 08714729985051. Document Number/Revision: 92328632-09, Rev A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2558-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2558-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-24	2025-09-12

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)