Quick Facts at a Glance
- Recall Date
- July 8, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific Neuromodulation
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, INFANTS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Boston Scientific Neuromodulation
- Product type
- Deep Brain Stimulation System
- Model numbers
- UDI-DI: 08714729985044, 08714729985051, Document Number/Revision: 92328632-09, Rev A
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 8, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Neuromodulation Corporation or your healthcare provider for instructions. Notification method: Letter
About This Product
Vercise Deep Brain Stimulation Systems provide targeted neural therapy for movement disorders. Devices implanted submuscularly to deliver stimulation.
Why This Is Dangerous
Wire breaks can interrupt stimulation and cause high impedances, leading to loss of therapy and possible adverse sensations or Bluetooth issues.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Urgent medical device issue requiring clinician coordination. Potential for device removal and replacement.
Practical Guidance
How to identify if yours is affected
- Check device labeling for UDI-DI 08714729985044 or 08714729985051.
- Review Document 92328632-09 Rev A.
- Consult clinician if you suspect device exposure.
Where to find product info
UDI-DI on implant labeling; recall document in FDA enforcement page linked in the notice.
What timeline to expect
Replacement or remediation timelines vary by patient and clinician guidance; expect medical scheduling coordinated by healthcare providers.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer and clinician.
- File a complaint with the FDA if necessary.
- Seek legal counsel if delays compromise safety.
How to prevent similar issues
- Coordinate with clinician for monitoring.
- Keep documentation intact for recalls.
- Ensure devices are checked during follow-up appointments.
Documentation advice
Save recall notice, document communications, and keep device labels and UDI-DI.
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Product Details
Model numbers: UDI-DI 08714729985044 and 08714729985051. Document Number: 92328632-09. Rev A. Distribution: Worldwide. Quantity: 25,260.
Reported Incidents
No specific incidents or injuries are detailed in the provided recall notice.
Key Facts
- Documents: 92328632-09, Rev A
- High hazard level with device removal possible
- Worldwide distribution including many US states and multiple countries
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Safety Guide
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