Infinion ProRecalls & reported problems across all models
Boston Scientific Neuromodulation Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 87
- Deaths reported
- 1
- Injuries reported
- 80
- Recalls
- 0
We found 2 models of Infinion Pro by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 87 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2024 and Sep 30, 2026 — classified as 1 death, 80 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Migration” (42 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 Infinion Pro problems
Device problems
- Migration42
- Adverse Event Without Identified Device or Use Problem29
- Unexpected Therapeutic Results28
- High impedance10
- Positioning Problem2
- Charging Problem1
- Device Fell1
- Fracture1
Patient problems
- Pain38
- No Clinical Signs, Symptoms or Conditions23
- Cerebrospinal Fluid Leakage7
- Bacterial Infection6
- Erosion4
- Fluid Discharge4
- Swelling/ Edema4
- Discomfort3
Infinion Pro models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Infinion™ Pro SC-2318-70Stimulator, spinal-cord, totally implanted for pain relief1 death46 reports
- Infinion™ Pro SC-2318-50Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy41 reports
Recent Infinion Pro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Unexpected Therapeutic Results; Migration
It was reported that the patient was experiencing loss of efficiency from the spinal cord stimulator (SCS). It was also stated that the patient's right spinal cord stimulator (SCS) lead had migrated two vertebral bodies which was confirmed through Xray. The patient had a device optimization was done without success. The patient underwent a lead replacement procedure and the patient was doing well postoperatively. The explanted lead was discarded by the medical facility and will not be returned.
Patient problems: Pain
MAUDE report 50942711 ↗InjurySep 30, 2026High impedance
It was reported that during an implant procedure, the physician could not clear up the high impedances on the lead. The physician opted to use a new lead, and impedances were all green and clear.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942447 ↗InjurySep 25, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898459 ↗InjurySep 15, 2026High impedance
Patient problems: Inappropriate Device Stimulation of Tissue; Pain
MAUDE report 50780726 ↗InjurySep 15, 2026Unexpected Therapeutic Results; Migration
It was reported that X-ray revealed that the left lead had migrated down and patient had an inadequate stimulation as a result. It was attempted to push the lead back into place but was unsuccessful. The physician opted to explant the lead along with the clik anchor. A new clik anchor was put in. The explanted products will not be returned per hospital policy, and patient was doing well postoperatively.
Patient problems: Pain
MAUDE report 50766985 ↗InjurySep 14, 2026Migration
Patient problems: Fall
MAUDE report 50765613 ↗InjuryAug 19, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333781 ↗InjuryAug 18, 2026High impedance; Unexpected Therapeutic Results; Migration
It was reported that the patient was not feeling any relief and leads had impedances and migrated. The patient underwent lead repositioning procedure. Patient was doing great postoperatively.
Patient problems: Pain
MAUDE report 50311695 ↗MalfunctionAug 11, 2026Migration
It was reported that the patient experienced lead migration due to a fall. It was noted that lead migration was confirmed through imaging, however, the patient still received good stimulation coverage.
Patient problems: Fall; Unspecified Respiratory Problem
MAUDE report 50202725 ↗InjuryAug 6, 2026High impedance
It was reported that the leads had high impedances. The patient underwent a lead replacement procedure and was doing well postoperatively. The explanted devices were not returned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164257 ↗InjuryJul 6, 2026Unexpected Therapeutic Results
IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) LEAD REPLACEMENT PROCEDURE FOR LOW BACK COVERAGE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE NOT RETURNED PER FACILITY POLICY.
Patient problems: Pain
MAUDE report 25719196 ↗MalfunctionJul 3, 2026Device Fell
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE LEAD WAS DROPPED TO THE FLOOR. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25707119 ↗InjuryJun 23, 2026Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION AND THE LEADS HAD MIGRATED OUT OF THE EPIDURAL SPACE. THE PATIENT UNDERWENT A LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE DISCARDED PER HOSPITAL POLICY.
Patient problems: Pain
MAUDE report 25589179 ↗InjuryMay 13, 2026Unexpected Therapeutic Results
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STIMULATION ON NON TARGET AREA. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN ONE OF THE LEADS WAS EXPLANTED AND THE OTHER LEAD WAS REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED LEAD WAS DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 25160533 ↗InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the spinal cord stimulation (SCS) patient developed an infection at the anchor site. The patient had symptoms of redness, swelling, tenderness, and a temperature. There were no device issues, however, the patient underwent an explant procedure to have all devices explanted. The patient was also treated with antibiotics. At the post-op wound review, there were no signs of infection and the patient was healing as expected with no further complications. A culture was performed but results were not provided. The physician stated that it was most likely a superficial infection from the incision. All explanted devices were discarded by the medical facility.Additional information was received that cultures were taken and it was indicative of a skin infection. However, the physician assessed that the infection was not related to any of the devices but rather something the patient managed to pick up.
Patient problems: Erythema; Fever; Swelling/ Edema; Unspecified Infection
MAUDE report 25089322 ↗
Other Boston Scientific Neuromodulation Corporation products
- Precision Spectra3 models · 11,348 reports
- Spectra WaveWriter4 models · 7,251 reports
- Precision17 models · 6,725 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
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.
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