VerityRecalls & reported problems across all models
St. Jude Medical, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 304
- Deaths reported
- 1
- Injuries reported
- 132
- Recalls
- 0
We found 8 models of Verity by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 304 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 4, 2026 — classified as 1 death, 132 injuries, 171 malfunctions.
The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (45 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 Verity problems
Device problems
- Pacemaker Found in Back-Up Mode45
- Failure to Interrogate35
- Premature Discharge of Battery34
- Adverse Event Without Identified Device or Use Problem31
- Incorrect Measurement19
- Misconnection19
- Data Problem17
- Failure to Disconnect17
Patient problems
- No Clinical Signs, Symptoms or Conditions123
- No Known Impact Or Consequence To Patient112
- Unspecified Infection22
- Dizziness15
- No Consequences Or Impact To Patient14
- Pocket Erosion10
- Syncope/Fainting8
- Arrhythmia6
Verity models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Verity™ ADx XL DRimplantable pacemaker Pulse-generator100 reports
- Verity® ADx XL SRProgrammer, pacemaker81 reports
- Verity™ ADx XL VDRimplantable pacemaker Pulse-generator59 reports
- Verity® ADx XL SCProgrammer, pacemaker33 reports
- Verity™ ADx XL DCimplantable pacemaker Pulse-generator20 reports
- Verity™ ADx XL SRProgrammer, pacemaker5 reports
- Verity™ ADx XL DRimplantable pacemaker Pulse-generator3 reports
- Verity™ ADx XL VDRimplantable pacemaker Pulse-generator1 death3 reports
Recent Verity adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 4, 2026Unexpected Mode Switch
It was reported that the patient presented to hospital for a follow up. It was noted that the pacemaker was in backup VVI mode due to elective replacement indicator (ERI). The pacemaker was explanted and replaced. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50604841 ↗MalfunctionJun 14, 2026Unexpected Mode Switch
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW UP IN CLINIC. IT WAS NOTED THAT THE PACEMAKER WENT INTO BACK UP MODE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN A STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25497818 ↗InjuryApr 6, 2026Failure to Capture
ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS REPROGRAMMED TO RESOLVE EVENT.
Patient problems: Syncope/Fainting
MAUDE report 24794134 ↗MalfunctionMar 13, 2026No Apparent Adverse Event
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 24590436 ↗MalfunctionJan 30, 2026Low impedance
IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED TO THE CLINIC FOR A SCHEDULED VISIT. UPON INTERROGATION, LEAD IMPEDANCE MEASUREMENT WAS LOW AND OUT-OF-RANGE. NO INTERVENTION WAS REPORTED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24222332 ↗MalfunctionJan 7, 2026Difficult to Remove
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN FOUND IT IMPOSSIBLE TO REMOVE THE LEADS FROM THE DEVICE BECAUSE OF A DEFECT IN THE SCREW IT WAS NOT GRIPPING. AFTER MULTIPLE ATTEMPTS THE LEAD WAS REMOVED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23992580 ↗MalfunctionDec 29, 2025Unexpected Mode Switch; Unexpected Mode Switch
IT WAS REPORTED THAT THE PATIENT¿S PACEMAKER WAS FOUND IN BACKUP MODE. NO CHANGES OR INTERVENTIONS WERE REPORTED, AND THE PATIENT¿S CONDITION WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 23904247 ↗InjuryJul 1, 2025No Pacing; No Pacing
IT WAS REPORTED THAT THE LOSS OF PACING WAS OBSERVED ON THE DEVICE. DISLODGEMENT OF THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED. DURING REVISION, THE RV LEAD WAS REPOSITIONED BUT LOSS OF PACING WAS OBSERVED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: Fatigue; Syncope/Fainting
MAUDE report 22372437 ↗MalfunctionMay 20, 2025Break; Loose or Intermittent Connection; Failure to Disconnect; Break; Loose or Intermittent Connection; Failure to Disconnect
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR GENERATOR EXPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SET SCREW OF THE PACEMAKER WAS STRIPPED WHICH RESULTED IN THE RIGHT VENTRICULAR LEAD FAILED TO BE REMOVED FROM THE PACEMAKER HEADER. IT WAS ALSO NOTED THAT THE SET SCREW AND THE LEAD WERE DAMAGED. THE PACEMAKER WAS EXPLANTED AND THE LEAD WAS CAPPED ON (B)(6) 2025. THE PATIENT WAS RECOVERING AND STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22050274 ↗InjuryApr 2, 2025Pacing Intermittently; Unexpected Mode Switch; Pacing Intermittently; Unexpected Mode Switch
IT WAS REPORTED THAT THE PATIENT WAS PRESENTED IN THE EMERGENCY ROOM WITH ARRHYTHMIA AND DIZZINESS. UPON FURTHER INTERROGATION, IT WAS NOTED THAT THE PACEMAKER HAD REVERT INTO BACK-UP MODE AND PACING INTERMITTENTLY. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Arrhythmia; Dizziness
MAUDE report 21751692 ↗MalfunctionFeb 19, 2025Failure to Disconnect; Failure to Disconnect
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-14552. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A PACEMAKER CHANGE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD FAILED TO BE REMOVED FROM THE PACEMAKER HEADER. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT REMAINED STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21417473 ↗MalfunctionFeb 14, 2025Failure to Disconnect; Failure to Disconnect
DURING A ROUTINE DEVICE EXCHANGE, THE SET SCREW OF THE DEVICE FAILED TO DISCONNECT FROM THE HEADER OF THE DEVICE. NO ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21384682 ↗MalfunctionJan 21, 2025Under-Sensing; Under-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW OF THE TRANSMISSION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED UNDERSENSING. THE PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21204571 ↗MalfunctionJan 14, 2025Break; Loose or Intermittent Connection; Connection Problem; Break; Loose or Intermittent Connection; Connection Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-10816. IT WAS REPORTED THAT PATIENT PRESENTED FOR A FOLLOW UP IN CLINIC. IT WAS NOTED THAT THE RIGHT ATRIAL LEAD EXHIBITED HIGH PACING IMPEDANCE. DURING THE LEAD REPLACEMENT PROCEDURE, IT WAS NOTED THAT THE HEADER FAILED TO LOCK THE LEAD ON THE PORT HENCE UNABLE TO RECONNECT THE LEAD. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2024. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21154825 ↗MalfunctionNov 3, 2024Loose or Intermittent Connection; Failure to Disconnect; Loose or Intermittent Connection; Failure to Disconnect
IT WAS REPORTED THAT THE DURING GENERATOR CHANGE PROCEDURE, THE SET SCREW OF THE PACEMAKER (PM) WAS STRIPPED, AND THE LEFT VENTRICLE (LV) LEAD WAS UNABLE TO BE REMOVED FROM THE HEADER OF THE PACEMAKER. THE PACEMAKER WAS EXPLANTED AND REPLACED WITH A NEW PACEMAKER ON (B)(6) 2024. ADDITIONALLY ON (B)(6) 2024, THE LV LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20595725 ↗
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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