Infinion CXRecalls & 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
1 open recall names at least one Infinion CX model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,139
- Deaths reported
- 1
- Injuries reported
- 1,864
- Recalls
- 1
We found 2 models of Infinion CX by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 2,139 adverse event reports in the FDA's MAUDE database, received between Jan 2, 2017 and Sep 28, 2026 — classified as 1 death, 1,864 injuries, 274 malfunctions.
The most frequently reported specific device problem is “High impedance” (1,306 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
Infinion CX 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.
- Jun 17, 2026Open, Classified
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.
Z-2879-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
Most reported Infinion CX problems
Device problems
- High impedance1,306
- Unexpected Therapeutic Results1,216
- Migration598
- Fracture322
- Adverse Event Without Identified Device or Use Problem201
- Inappropriate/Inadequate Shock/Stimulation41
- Charging Problem32
- Defective Device25
Patient problems
- No Clinical Signs, Symptoms or Conditions671
- Pain565
- Inadequate Pain Relief449
- No Code Available419
- Undesired Nerve Stimulation100
- Discomfort46
- No Known Impact Or Consequence To Patient35
- Cerebrospinal Fluid Leakage34
Infinion CX models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Infinion™ CX SC-2317-70STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall1 death1,268 reports
- Infinion™ CX SC-2317-50STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall871 reports
Recent Infinion CX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Unexpected Therapeutic Results; Charging Problem; Migration
Patient problems: Pain
MAUDE report 50923928 ↗MalfunctionSep 28, 2026High impedance; Migration
It was reported that after a fall, it was found out that the right lead had two impedances and the lead had possibly migrated but was unable to confirm it. After program optimization, the patient got good coverage.
Patient problems: Fall
MAUDE report 50910714 ↗InjurySep 23, 2026High impedance
Patient problems: Discomfort; Pain
MAUDE report 50874514 ↗InjurySep 22, 2026High impedance; Unexpected Therapeutic Results
Patient problems: Pain
MAUDE report 50849379 ↗InjurySep 21, 2026High impedance; Charging Problem
It was reported that the patient was unable to have a Magnetic Resonance Imaging (MRI) due to concern for abnormal lead impedance from the Spinal Cord Stimulator (SCS) device. It was also reported that the patients Implantable Pulse Generator (IPG) was no longer keeping a charge. The patient underwent a revision procedure wherein the IPG, SCS leads and Clik anchor were replaced. The patient was reported to be doing well post operatively. The explanted device components were not returned due to facility policy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836113 ↗InjurySep 19, 2026Fracture; High impedance; Unexpected Therapeutic Results; Migration
Patient problems: Pain
MAUDE report 50831660 ↗InjurySep 18, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831298 ↗InjurySep 18, 2026High impedance; Unexpected Therapeutic Results
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 50828714 ↗InjurySep 17, 2026High impedance; Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812338 ↗InjurySep 15, 2026High impedance
It was reported that the patient had high impedances on the leads. The patient underwent a Spinal Cord Stimulator (SCS) system replacement procedure. The explanted products will not be returned per hospital policy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767166 ↗InjuryAug 28, 2026High impedance
It was reported tha the patient had a new area of pain in her upper back, and the leads had high impedances. The patient underwent a Spinal Cord Stimulator (SCS) system replacement procedure.Additional information was received that the explanted products were discarded per hospital policy and patient was doing well postoperatively.
Patient problems: Pain
MAUDE report 50509726 ↗InjuryAug 28, 2026High impedance
It was reported that the leads had high impedances. The patient underwent a Spinal Cord Stimulator (SCS) system explant procedure and was doing well postoperatively. The explanted devices were discarded by the facility.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50490374 ↗InjuryAug 21, 2026Unexpected Therapeutic Results; Charging Problem
Patient problems: Implant Pain; Pain
MAUDE report 50383810 ↗InjuryAug 19, 2026Unexpected Therapeutic Results; Migration
It was reported that the patient was no longer getting a relief due to lead migration that was confirmed via X-ray. All components were explanted. No further information has been obtained.
Patient problems: Pain
MAUDE report 50315445 ↗InjuryAug 18, 2026High impedance; Unexpected Therapeutic Results
It was reported that the patient was experiencing inadequate pain relief. The patients battery was moving more laterally away from her spine and leads had high impedances. The patient underwent spinal cord stimulation (SCS) replacement procedure. The patient was doing well postoperatively.
Patient problems: Pain
MAUDE report 50290597 ↗
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
- 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.
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