St. Jude Medical InfinityRecalls & reported problems across all models
St. Jude Medical, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,773
- Deaths reported
- 18
- Injuries reported
- 1,918
- Recalls
- 1
We found 13 models of St. Jude Medical Infinity by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 2,773 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and Sep 30, 2026 — classified as 18 deaths, 1,918 injuries, 837 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (825 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
St. Jude Medical Infinity 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.
- Oct 11, 2018Terminated
The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
Z-0593-2019 · Root cause: Mixed-up of materials/components · names 4 of these models · Recall details · FDA record ↗
Most reported St. Jude Medical Infinity problems
Device problems
- Component Misassembled825
- Adverse Event Without Identified Device or Use Problem733
- High impedance497
- Therapeutic or Diagnostic Output Failure206
- Fracture149
- Impedance Problem91
- Migration71
- Low impedance69
Patient problems
- No Consequences Or Impact To Patient869
- Inadequate Pain Relief513
- No Clinical Signs, Symptoms or Conditions345
- Movement Disorder338
- Unspecified Infection224
- Failure of Implant138
- Post Operative Wound Infection136
- Erosion92
St. Jude Medical Infinity models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall3 deaths751 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR406 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall10 deaths306 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall226 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR268 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR263 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR237 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR5 deaths178 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR93 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall17 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR21 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR4 reports
- St. Jude Medical Infinity™ DBS SystemSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR3 reports
Recent St. Jude Medical Infinity adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50952989 ↗InjurySep 29, 2026High impedance
It was reported that the patient experienced a shocking sensation and was unable to enter their device into MRI mode. Diagnostics revealed high impedances on bilateral extensions. As a result, surgical intervention was undertaken wherein the bilateral extensions were explanted and replaced to resolve the issue.
Patient problems: Undesired Nerve Stimulation
MAUDE report 50933664 ↗InjurySep 29, 2026High impedance
It was reported that the patient experienced a shocking sensation and was unable to enter their device into MRI mode. Diagnostics revealed high impedances on bilateral extensions. As a result, surgical intervention was undertaken wherein the bilateral extensions were explanted and replaced to resolve the issue.
Patient problems: Undesired Nerve Stimulation
MAUDE report 50933656 ↗InjurySep 25, 2026Failure to Deliver Energy
It was reported that patients system was auto reducing. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Movement Disorder
MAUDE report 50903696 ↗InjurySep 23, 2026High impedance
Patient problems: Movement Disorder
MAUDE report 50875987 ↗InjurySep 23, 2026High impedance
Patient problems: Movement Disorder
MAUDE report 50875956 ↗InjurySep 22, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862128 ↗InjurySep 22, 2026Therapeutic or Diagnostic Output Failure
It was reported that the patient experienced returning symptoms. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was replaced to address the issue. Therapy was restored post-operatively.
Patient problems: Movement Disorder
MAUDE report 50860270 ↗InjurySep 21, 2026High impedance
It was reported that patient was unable to enter MRI mode due to high impedance. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein extension was unplugged whipped off and reinserted to address the issues. Impedance cleared.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846235 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported patient had infection at the burr hole site. Investigation was unable to identify which burr hole cap attributed to the issue. Surgical intervention was undertaken wherein the left lead and burr hole were removed. Patient was prescribed anti-biotics to address the issue.
Patient problems: Unspecified Infection
MAUDE report 50828391 ↗InjurySep 17, 2026High impedance
It was reported the patient's leads had high impedances. Surgical intervention was undertaken wherein the leads were explanted and replaced to address the issue.
Patient problems: Movement Disorder
MAUDE report 50806844 ↗InjurySep 17, 2026High impedance
It was reported the patient's leads had high impedances. Surgical intervention was undertaken wherein the leads were explanted and replaced to address the issue.
Patient problems: Movement Disorder
MAUDE report 50806831 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fluid Discharge; Impaired Healing
MAUDE report 50794952 ↗InjurySep 14, 2026High impedance
It was reported that patient's system was unable to enter MRI mode. Troubleshooting revealed high impedances on the right lead. As a result, surgical intervention was undertaken on (b)(6)2026 wherein the lead extension was replaced to address the issue. Therapy was restored post-operatively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763996 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703216 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 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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