Verity™ ADx XL VDR (REF 5456)Recalls & reported problems
St. Jude Medical, Inc. · Pulse Generator VDDR · Class 3 · Implant
All models of Verity (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Verity ADx XL VDR is an implantable pacemaker pulse generator. The 59 reports mostly describe the device being hard to read or interrogate, showing data errors or wrong measurements, dropping into a backup mode, or its battery draining early; 14 reports involved injuries and no deaths. In several cases the device or its lead stopped pacing, needed reprogramming, or was removed and replaced. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 05414734006910), received between Aug 31, 2018 and Apr 6, 2026 — classified as 14 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Failure to Interrogate” (12 reports).
9 other recalls cover devices cleared under the same FDA submission (P880086); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Interrogate12
- Data Problem10
- Premature Discharge of Battery8
- Incorrect Measurement7
- Pacemaker Found in Back-Up Mode6
- Interrogation Problem4
- Loose or Intermittent Connection3
- Misconnection3
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Known Impact Or Consequence To Patient16
- Bradycardia2
- Syncope/Fainting2
- Fatigue1
- Insufficient Information1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionJan 22, 2024Incorrect Measurement; Incorrect Measurement
DURING A CLINIC FOLLOW-UP, A DIAGNOSTIC ANOMALY WAS OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18554822 ↗MalfunctionDec 6, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT A DIAGNOSTIC ANOMALY WAS OBSERVED ON THE DEVICE. THE EVENT WAS RESOLVED BY REINTERROGATING THE DEVICE AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18277749 ↗InjuryNov 30, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode
DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS FOUND TO BE IN BACKUP VVI (BVVI) MODE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, HOWEVER, THE CAUSE OF THE BVVI COULD NOT BE DETERMINED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18237600 ↗InjurySep 6, 2023Premature Discharge of Battery; Capturing Problem; Premature Discharge of Battery; Capturing Problem
NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17695325 ↗MalfunctionJun 26, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE SET SCREW WAS MISSING WHEN THE ATRIAL LEAD WAS BEING CONNECTED TO THE DEVICE DURING IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17200171 ↗MalfunctionMar 27, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE, THE SET SCREW OF THE DEVICE WAS UNABLE TO BE TIGHTENED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16619485 ↗MalfunctionMar 21, 2023Over-Sensing; Over-Sensing
DURING A CLINIC FOLLOW-UP, EPISODES OF POST-PACED T WAVE OVERSENSING WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED, BUT NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16583688 ↗MalfunctionFeb 28, 2023Data Problem; Data Problem
IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, AN ERROR MESSAGE WAS RECEIVED INDICATING PROGRAMMER MODEL 3510 IS REQUIRED TO INTERROGATE THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16455439 ↗MalfunctionJan 10, 2023Battery Problem; Battery Problem
DURING A CLINIC FOLLOW-UP, AN INCREASE IN THE BATTERY'S IMPEDANCE WAS OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED, BUT NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16130880 ↗MalfunctionOct 3, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
DURING THE IMPLANT PROCEDURE, THE SET SCREW WAS UNABLE TO BE TIGHTENED. THE EVENT WAS RESOLVED BY REPLACING THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15534547 ↗InjuryAug 15, 2022Premature Discharge of Battery; Premature Discharge of Battery
DURING AN IN CLINIC FOLLOW-UP, THE DEVICE WAS FOUND TO BE AT ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THAN EXPECTED. PREMATURE DEPLETION OF THE BATTERY WAS SUSPECTED. A DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15227382 ↗InjuryJun 27, 2022Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14836402 ↗MalfunctionJun 21, 2022Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, A HIGH BATTERY IMPEDANCE VALUE WAS NOTED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND THE BATTERY IMPEDANCE VALUE WAS SUSPECTED TO BE AN INCORRECT MEASUREMENT. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14754942 ↗MalfunctionMay 11, 2022Failure to Interrogate; Failure to Interrogate
DURING DEVICE PREPARATION FOR THE IMPLANT PROCEDURE, INTERROGATION OF THE DEVICE WAS NOT POSSIBLE. THE EVENT WAS RESOLVED BY REPLACING AND IMPLANTING A NEW DEVICE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14364971 ↗MalfunctionMar 10, 2022Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A ROUTINE PULSE GENERATOR CHANGE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE LEAD WAS UNABLE TO BE REMOVED FROM THE HEADER AFTER THE SETSCREW WAS ALREADY REMOVED. MULTIPLE ATTEMPTS WERE MADE TO DISCONNECT THE LEAD FROM THE HEADER; THE LEAD WAS DAMAGED. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13726770 ↗MalfunctionFeb 3, 2022Incorrect Measurement; Pacemaker Found in Back-Up Mode; Incorrect Measurement; Pacemaker Found in Back-Up Mode
DURING FOLLOW-UP, THE DEVICE WAS FOUND TO HAVE REACHED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND CONFIRMED THAT BATTERY DEPLETION WAS NORMAL. IT WAS SUSPECTED THAT OVERESTIMATION OCCURRED AT A PREVIOUS FOLLOW-UP. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE DEVICE WAS FOUND IN BACK-UP MODE FOLLOWING DEVICE EXPLANT DUE TO HAVING REACHED END OF SERVICE (EOS). THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13443190 ↗MalfunctionJan 10, 2022Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS INTERROGATED AND REVEALED THAT THE BATTERY WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). HOWEVER, THE BATTERY VOLTAGE WAS NOT AT ERI LEVELS. TECHNICAL SUPPORT WAS CONTACTED AND CONFIRMED THAT A FALSE ERI ALERT HAD BEEN DELIVERED AND THE BATTERY VOLTAGE LEVELS WERE ACCURATE. NO INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13207148 ↗InjuryDec 13, 2021Premature Discharge of Battery; Premature Discharge of Battery
NEW INFORMATION RECEIVED NOTES THE PACEMAKER WAS EXPLANTED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12986817 ↗MalfunctionOct 7, 2021Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT PRIOR TO AN IMPLANT PROCEDURE, THE DEVICE WAS UNABLE TO BE INTERROGATED USING INDUCTIVE TELEMETRY. THE DEVICE WAS NOT IMPLANTED AND ANOTHER DEVICE WAS IMPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12590521 ↗MalfunctionOct 5, 2021Interrogation Problem; Interrogation Problem
IT WAS REPORTED THAT IN A NON-CLINICAL ENVIRONMENT, THE PACEMAKER (PM) HAD A INDUCTIVE TELEMETRY ISSUE WHEN CHECKING THE DEVICE IN THE DISTRIBUTOR WAREHOUSE. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12578051 ↗MalfunctionOct 1, 2021Interrogation Problem; Interrogation Problem
IT WAS REPORTED THAT IN A NON-CLINICAL ENVIRONMENT, THE PACEMAKER (PM) HAD A INDUCTIVE TELEMETRY ISSUE WHEN CHECKING THE DEVICE IN THE DISTRIBUTOR WAREHOUSE. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12562616 ↗MalfunctionAug 17, 2021Data Problem; Interrogation Problem; Data Problem; Interrogation Problem
IT WAS REPORTED THAT THE PACEMAKER WAS MALFUNCTIONING. DURING DEVICE CHECK, IT WAS NOTED THAT THE PACEMAKER HAD AN ERROR MESSAGE WHILE TRYING TO INTERROGATE. THERE WAS ALSO AN INTERROGATION PROBLEM WITH THE PACEMAKER. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12333550 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P880086. One submission often covers many models, so check the product and lot details in each record.
- Z-1495-2022 · Jun 17, 2022 · Open, ClassifiedMerlin PCS 3650 programmer Model 3330 software
- Z-1496-2022 · Jun 17, 2022 · Open, ClassifiedMerlin 2 PCS MER37000 programmer Model MER3400 software
- Z-1497-2022 · Jun 17, 2022 · Open, ClassifiedMerlin.net model MN5000 Software
- Z-0430-2012 · Sep 23, 2011 · TerminatedAnthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
- Z-0429-2012 · Sep 23, 2011 · TerminatedImplantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
- Z-0298-2007 · Oct 6, 2006 · TerminatedSt. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
- Z-0296-2007 · Oct 6, 2006 · TerminatedSt. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
- Z-0297-2007 · Oct 6, 2006 · TerminatedSt. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
- Z-0052-04 · Jul 31, 2003 · TerminatedPulse Generator
Other implantable pacemaker Pulse-generator devices
- CareLink Encore™ 29901Medtronic, Inc. · implantable pacemaker Pulse-generator3 recalls265 reports
- Victory™ 5816St. Jude Medical, Inc. · implantable pacemaker Pulse-generator5 deaths347 reports
- Identity™ 5386St. Jude Medical, Inc. · implantable pacemaker Pulse-generator3 deaths154 reports
- Verity™ ADx XL DRSt. Jude Medical, Inc. · implantable pacemaker Pulse-generator100 reports
- Identity™ 5286St. Jude Medical, Inc. · implantable pacemaker Pulse-generator53 reports
- NA 6725Medtronic, Inc. · implantable pacemaker Pulse-generator1 death39 reports
- Identity™ 5376St. Jude Medical, Inc. · implantable pacemaker Pulse-generator1 death26 reports
- Identity® 5480St. Jude Medical, Inc. · implantable pacemaker Pulse-generator21 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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