InfinityRecalls & reported problems across all models
St. Jude Medical, Inc. · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
6 open recalls name at least one Infinity model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,571
- Deaths reported
- 12
- Injuries reported
- 1,467
- Recalls
- 6
We found 6 models of Infinity by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,571 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and Sep 29, 2026 — classified as 12 deaths, 1,467 injuries, 92 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (664 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 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
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.
- May 22, 2024Class IIOpen, Classified
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Z-2432-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
- May 22, 2024Class IIOpen, Classified
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Z-2431-2024 · Root cause: Error in labeling · names 2 of these models · Recall details · FDA record ↗
- May 22, 2024Class IIOpen, Classified
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Z-2430-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
- May 22, 2024Class IIOpen, Classified
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Z-2429-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
- Jul 18, 2023Class IOpen, Classified
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Z-2511-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 18, 2023Class IOpen, Classified
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Z-2510-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Infinity problems
Device problems
- Battery Problem664
- Adverse Event Without Identified Device or Use Problem343
- Wireless Communication Problem138
- Insufficient Device Problem Information131
- No Apparent Adverse Event76
- Migration65
- Premature Elective Replacement Indicator53
- High impedance47
Patient problems
- Failure of Implant494
- Inadequate Pain Relief459
- Movement Disorder283
- No Clinical Signs, Symptoms or Conditions251
- Unspecified Infection106
- No Consequences Or Impact To Patient93
- Implant Pain70
- Post Operative Wound Infection69
Infinity models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Infinity™ 6662STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall3 deaths803 reports
- Infinity™ 7STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 recalls3 deaths368 reports
- Infinity™ 6660STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR5 deaths312 reports
- Infinity™ 5STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 recalls28 reports
- Infinity™ 7STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall1 death47 reports
- Infinity™ 6661STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall13 reports
Recent Infinity 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: Post Operative Wound Infection
MAUDE report 50939787 ↗InjurySep 22, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861341 ↗InjurySep 22, 2026Low impedance
It was reported that the patient was unable to place their system into MRI mode. Diagnostics revealed low impedances on the right lead. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was explanted and replaced to address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860398 ↗InjurySep 17, 2026Insufficient Device Problem Information
It was reported that the patient received a low battery warning. It is unknown if this occurred prematurely. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797721 ↗InjurySep 16, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795687 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fluid Discharge; Impaired Healing
MAUDE report 50794950 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient's IPG had broken through the skin. As a result, the IPG was explanted and replaced.
Patient problems: Fluid Discharge; Pocket Erosion
MAUDE report 50792827 ↗InjuryAug 5, 2026Premature Discharge of Battery
It was reported that the patient received a low battery warning. It is unknown if this occurred prematurely. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50139815 ↗InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient¿s extensions exhibited high impedances prior to the procedure. Patient was diagnosed with twiddler's syndrome. As a result, surgical intervention was undertaken wherein the extensions were untwisted and the IPG was replaced to address the issue.
Patient problems: Twiddlers Syndrome
MAUDE report 50125713 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced discomfort at the IPG site. As a result, surgical intervention was undertaken on 10JUL2026 wherein the IPG was explanted and replaced to address the issue.
Patient problems: Implant Pain
MAUDE report 50124387 ↗InjuryJun 30, 2026Migration
IT WAS REPORTED THE PATIENT¿S IPG HAD MIGRATED. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED, REPLACED AND SUTURED TO THE TOP OF THE POCKET TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673849 ↗InjuryJun 29, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT RECEIVED A LOW BATTERY WARNING. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25654944 ↗InjuryJun 25, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THE IPG REPLACED BY A DIFFERENT MANUFACTURER ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25626136 ↗InjuryJun 15, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. ADDITIONALLY, PATIENT WAS UNABLE TO SET THE IPG INTO MRI MODE. IMPEDANCE CHECK REVEALED HIGH IMPEDANCE. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026 WHEREIN THE EXTENSION WAS REMOVED AND REINSERTED INTO THE IPG HEADER RESOLVING THE ISSUE. IMPEDANCE READING NORMAL AND THERAPY WAS CONFIRMED POST OP.
Patient problems: Movement Disorder
MAUDE report 25512639 ↗InjuryJun 8, 2026Wireless Communication Problem
IT WAS REPORTED DURING AN I&D PROCEDURE, THE IPG BECAME INOPERABLE. AS A RESULT, THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.
Patient problems: Movement Disorder
MAUDE report 25435778 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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