PrecisionRecalls & reported problems across all models
Boston Scientific Neuromodulation Corporation · 17 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6,725
- Deaths reported
- 29
- Injuries reported
- 6,126
- Recalls
- 0
We found 17 models of Precision by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 6,725 adverse event reports in the FDA's MAUDE database, received between Nov 26, 2012 and Sep 29, 2026 — classified as 29 deaths, 6,126 injuries, 570 malfunctions.
The most frequently reported specific device problem is “Charging Problem” (2,891 reports).
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
Most reported Precision problems
Device problems
- Charging Problem2,891
- Adverse Event Without Identified Device or Use Problem1,860
- Unexpected Therapeutic Results1,129
- Defective Device558
- Premature Discharge of Battery424
- Failure to Charge231
- Device Inoperable208
- Delayed Charge Time175
Patient problems
- No Code Available2,925
- No Clinical Signs, Symptoms or Conditions1,713
- No Known Impact Or Consequence To Patient853
- Pain550
- Inadequate Pain Relief348
- No Information288
- Discomfort222
- Undesired Nerve Stimulation98
Precision models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Precision™ SC-1110-02STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF26 deaths6,519 reports
- Precision™ SC-1010CSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths45 reports
- Precision™ SC-6412-3STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF42 reports
- Precision™ SC-9218-15STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death30 reports
- Precision ™ SC-5312STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF27 reports
- Precision™ SC-1112STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF27 reports
- Precision™ SC-9208-15STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF15 reports
- Precision ™ SC-4230STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF5 reports
- Precision™ SC-9208-15ESTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF4 reports
- Precision™ SC-9004-35STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
- Precision™ SC-9218-55STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
- Precision ™ SC-1110-02STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
- Precision ™ SC-4350STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 report
- Precision™ SC-4275STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 report
- Precision ™ SC-6350STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 report
- Precision™ SC-9004-55STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 report
- Precision™ SC-9208-55STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 report
Recent Precision adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933792 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this Spinal Cord Stimulation (SCS) device was replaced due to an unknown reason. The location of the replaced device is unknown. Additional information has been requested; and will be provided as it becomes available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932060 ↗InjurySep 25, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899098 ↗InjurySep 24, 2026Charging Problem
It was reported that the patient was experiencing frequent Implantable Pulse Generator (IPG) charging. The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted device was not returned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878499 ↗InjurySep 22, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862914 ↗InjurySep 22, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862906 ↗InjurySep 22, 2026Unexpected Therapeutic Results
It was reported that the patient felt stimulation and burning sensation all around the body. The patient noted that they are supposed to feel stimulation at the back. The patient underwent an Implantable Pulse Generator (IPG) explant procedure.
Patient problems: Burning Sensation; Inappropriate Device Stimulation of Tissue
MAUDE report 50858098 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Pulse Generator (IPG) was no longer functioning as intended. The patient underwent an Implantable Pulse Generator (IPG) replacement procedure and was doing well postoperatively. The explanted device was not returned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50851442 ↗InjurySep 21, 2026Fracture; Nonstandard Device; Use of Device Problem
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 50848926 ↗InjurySep 21, 2026Nonstandard Device
It was reported that the patient underwent a Spinal Cord Stimulator (SCS) explant procedure due to device never worked as intended. No further information has been obtained despite good faith efforts.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846483 ↗InjurySep 21, 2026Charging Problem
It was reported that the patient's implanted pulse generator (IPG) was unable to charge. The patient subsequently underwent a surgical procedure. During the procedure, following incision at the battery site, a white discharge was observed, and wound irrigation specimens were obtained. The midline incision was also opened, no discharge was noted at that location. However, the physician observed granulation tissue beneath the currently implanted paddle lead. Given these findings, the physician elected not to implant new equipment and instead explanted the existing system. The physician reportedly did not believe the probable infection was device related and instead suspected an underlying inflammatory condition. Culture was obtained and the result was not yet available.
Patient problems: Fluid Discharge; Inflammation; Unspecified Infection
MAUDE report 50841698 ↗DeathSep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient implanted with a spinal cord stimulation (SCS) system passed away. The cause of death is unknown. No further information has been obtained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831205 ↗InjurySep 18, 2026Overheating of Device; Unexpected Therapeutic Results
Patient problems: Burning Sensation; Fall; Pain
MAUDE report 50831158 ↗InjurySep 18, 2026Battery Problem
It was reported that the patient's IPG had reached End of Life. The patient underwent a procedure wherein the implantable pulse generator (IPG) and spinal cord stimulator (SCS) leads were explanted. The explanted devices were discarded by the medical facility and will not be returned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817245 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Stroke/CVA
MAUDE report 50812339 ↗
Other Boston Scientific Neuromodulation Corporation products
- Precision Spectra3 models · 11,348 reports
- Spectra WaveWriter4 models · 7,251 reports
- WaveWriter Alpha3 models · 4,356 reports · 1 recall
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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