WaveWriter AlphaRecalls & reported problems across all models
Boston Scientific Neuromodulation Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one WaveWriter Alpha model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4,356
- Deaths reported
- 41
- Injuries reported
- 4,268
- Recalls
- 1
We found 3 models of WaveWriter Alpha by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 4,356 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2021 and Sep 30, 2026 — classified as 41 deaths, 4,268 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Charging Problem” (1,104 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
WaveWriter Alpha recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 17, 2024Open, Classified
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.
Z-2617-2024 · Root cause: Software design · Recall details · FDA record ↗
Most reported WaveWriter Alpha problems
Device problems
- Adverse Event Without Identified Device or Use Problem2,088
- Charging Problem1,104
- Unexpected Therapeutic Results1,005
- Migration434
- Wireless Communication Problem160
- Inappropriate/Inadequate Shock/Stimulation145
- High impedance92
- Positioning Problem88
Patient problems
- No Clinical Signs, Symptoms or Conditions1,454
- Pain1,113
- Implant Pain495
- Discomfort466
- Bacterial Infection402
- Unspecified Infection363
- Swelling/ Edema167
- Fluid Discharge159
WaveWriter Alpha models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- WaveWriter Alpha™ SC-1232Stimulator, spinal-cord, totally implanted for pain relief1 recall41 deaths4,347 reports
- WaveWriter Alpha™ SC-5170Stimulator, spinal-cord, totally implanted for pain relief8 reports
- WaveWriter Alpha™ SC-6500-72Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy1 report
Recent WaveWriter Alpha adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50955194 ↗MalfunctionSep 30, 2026Inappropriate/Inadequate Shock/Stimulation
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50954723 ↗InjurySep 30, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954719 ↗InjurySep 30, 2026Charging Problem
Patient problems: Back pain; Pain
MAUDE report 50952860 ↗InjurySep 30, 2026Migration
Patient problems: Implant Pain
MAUDE report 50951798 ↗InjurySep 30, 2026Unexpected Therapeutic Results
Patient problems: Pain
MAUDE report 50949832 ↗InjurySep 30, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949343 ↗InjurySep 30, 2026Wireless Communication Problem
It was reported that the patient was hospitalized for an unknown reason. The implantable pulse generator (IPG) had difficulty communicating with the remote. No further information has been obtained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947146 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implantable pulse generator (IPG) site appeared to be infected. Laboratory testing was performed, and the white blood cell count was reported to be within normal limits. The physician indicated that the event was not believed to be related to the stimulator and noted that the patient had diabetes with a history of poor healing. All device components were explanted and were not returned for evaluation. The patient was doing well postoperatively.
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 50944762 ↗InjurySep 29, 2026Unexpected Therapeutic Results
Patient problems: Pain
MAUDE report 50940886 ↗InjurySep 29, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938246 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938242 ↗InjurySep 29, 2026Nonstandard Device
It was reported that the patient was involved in a motor bike accident which caused the spinal cord stimulator (SCS) implantable pulse generator (IPG) to be damaged. It was stated that there was no issue with the devices prior to the accident. The patient underwent a revision procedure where the IPG and SCS leads were removed and replaced. The device had been turned off since the accident and battery depleted so it was not possible to see what was working and what was not therefore, both the IPG and leads were replaced. Post operatively, the patient was stable. The explanted devices will not be returned as they were disposed by the physician.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936045 ↗InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation
It was reported that patient is experiencing pain and feels a strong shocking feeling on left heel.
Patient problems: Inappropriate Device Stimulation of Tissue; Pain
MAUDE report 50933347 ↗MalfunctionSep 29, 2026Inappropriate/Inadequate Shock/Stimulation
It was reported that the patient felt a zap near the Implantable Pulse Generator (IPG) site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930231 ↗
Other Boston Scientific Neuromodulation Corporation products
- Precision Spectra3 models · 11,348 reports
- Spectra WaveWriter4 models · 7,251 reports
- Precision17 models · 6,725 reports
- Precision Montage MRI2 models · 4,332 reports
- Linear ST5 models · 4,068 reports
- Infinion CX2 models · 2,139 reports · 1 recall
- Superion5 models · 1,488 reports · 2 recalls
- Infinion 165 models · 1,550 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page