Verity™ ADx XL DR (REF 5356)Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 05414734006835), received between Jun 11, 2018 and Apr 2, 2025 — classified as 45 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (18 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• 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 26, 2024Failure to Disconnect; Failure to Disconnect

  DURING A DEVICE REPLACEMENT PROCEDURE, IT WAS NOT POSSIBLE TO REMOVE THE LEAD FROM THE HEADER OF THE DEVICE. THE LEAD WAS CUT AND A NEW DEVICE AND LEAD WERE IMPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784012 ↗
• InjuryJan 7, 2024Data Problem; Data Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED ERROR MESSAGE, THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461486 ↗
• InjuryDec 7, 2023Failure to Interrogate; Failure to Interrogate

  DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS UNABLE TO BE INTERROGATED. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, AND THE DEVICE SOFTWARE WAS UPGRADED, HOWEVER, THE DEVICE WAS STILL UNABLE TO BE INTERROGATED. DEVICE REPLACEMENT IS ANTICIPATED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18284967 ↗
• MalfunctionOct 30, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE SET SCREW OF THE RIGHT ATRIAL (RA) PORT COULD NOT BE UNSCREWED FROM THE HEADER OF THE DEVICE. THE DEVICE WAS REPLACED TO RESOLVE THE EVENT. THE RA LEAD WAS CAPPED AND THE RA PORT WAS PLUGGED DUE TO PATIENT CONDITION. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030793 ↗
• MalfunctionOct 13, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT DURING GENERATOR EXCHANGE DEVICE INTERROGATION REVEALED FAILURE TO CAPTURE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936318 ↗
• MalfunctionOct 12, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED, PRIOR TO DEVICE REPLACEMENT FOR NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) THE DEVICE WAS UNABLE TO BE INTERROGATED USING INDUCTIVE TELEMETRY. THE DEVICE WAS REPLACED AS ANTICIPATED FOR NORMAL ERI. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17924141 ↗
• MalfunctionSep 7, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT SET SCREW WAS UNABLE TO BE REMOVED FROM THE DEVICE HEADER DURING A DEVICE DOWNGRADE PROCEDURE. 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 17701178 ↗
• MalfunctionJul 31, 2023Loose or Intermittent Connection; Difficult to Remove; Loose or Intermittent Connection; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE GENERATOR CHANGEOUT PROCEDURE. DURING THE SURGERY, THE SET SCREW ON THE PACEMAKER WAS STRIPPED AND CALCIFICATION MADE IT DIFFICULT TO REMOVE THE LEADS FROM THE HEADER. THE LEAD WAS FREED AND THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431255 ↗
• InjuryJul 28, 2023Pacemaker Found in Back-Up Mode; Inappropriate or Unexpected Reset; Pacemaker Found in Back-Up Mode; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A PATIENT PRESENTED FOR ELECTIVE GENERATOR CHANGE. DEVICE INTERROGATION REVEALED THAT THE PACEMAKER (PM) WAS IN BACKUP MODE. THE PM WAS UNABLE TO BE RESTORED BACK TO NORMAL SETTINGS. THE PHYSICIAN EXPLANTED AND REPLACED THE PM. THE PATIENT CONDITION WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421359 ↗
• MalfunctionJul 19, 2023Failure to Disconnect; Failure to Disconnect

  DURING A ROUTINE DEVICE EXCHANGE PROCEDURE, IT WAS REPORTED ONE OF THE VENTRICULAR LEAD WAS UNABLE TO BE DISCONNECTED FROM THE DEVICE HEADER. THE LEAD WAS CUT, CAPPED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350633 ↗
• InjuryApr 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN THE CLINIC WITH SKIN EROSION AND INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE PHYSICIAN EXPLANTED THE ENTIRE PACEMAKER SYSTEM TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 16661084 ↗
• MalfunctionMar 10, 2023Pacing Asynchronously; Under-Sensing; Pacing Asynchronously; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS DUE TO UNDERSENSING ON THE DEVICE RESULTING IN FUNCTIONAL LOSS OF CAPTURE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Dizziness

  MAUDE report 16522969 ↗
• InjuryFeb 10, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16352094 ↗
• InjuryJan 6, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE PACEMAKER WAS FAILING TO BE INTERROGATED VIA INDUCTIVE TELEMETRY. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110408 ↗
• MalfunctionDec 21, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A DEVICE CHECK. UPON REVIEW, THE PACEMAKER SHOWED NO DATA POPULATING THE BATTERY LONGEVITY, CURRENT DRAIN, AND VOLTAGE FIELDS. RE-INTERROGATION SHOWED THE SAME ANOMALY. TECH SERVICES WAS CONTACTED AND IT WAS NOTED THAT THE PACEMAKER WOULD SHOW SUCH ANOMALY WITH PATIENTS WHO ARE USING VERY LOW PACING PERCENTAGES. IT WAS RECOMMENDED THAT THE PATIENT COME BACK INTO THE OFFICE AND A HIGHER BASE RATE BE PROGRAMMED SO THAT THE DEVICE COULD READ AND MEASURE DATA AND THEN SUBSEQUENTLY LOWER THE BASE RATE. NO INTERVENTION WAS PERFORMED. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022761 ↗
• InjuryNov 15, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER WAS FOUND IN BACK-UP VVI MODE DUE TO THRESHOLD TESTING. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795683 ↗
• MalfunctionNov 9, 2022Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE OPERATION ROOM FOR A GENERATOR CHANGE. DURING THE PROCEDURE, THE PHYSICIAN FAILED TO LOOSEN THE SET SCREW ON THE PACEMAKER TO DISCONNECT THE RIGHT VENTRICULAR (RV) LEAD, AND THE PHYSICIAN DECIDED TO CUT THE RV LEAD FROM THE PACEMAKER. THE PACEMAKER WAS EXPLANTED AND REPLACED WITH AN ALTERNATE PACEMAKER. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758934 ↗
• MalfunctionOct 5, 2022Failure to Disconnect; Failure to Disconnect

  DURING A ROUTINE DEVICE EXCHANGE PROCEDURE TO ADDRESS NORMAL BATTERY DEPLETION, THE NON-ABBOTT RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO BE REMOVED FROM THE HEADER OF THE DEVICE. THE RV LEAD WAS CUT IN ORDER TO SUCCESSFULLY EXPLANT AND REPLACE THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546846 ↗
• MalfunctionJul 15, 2022Failure to Disconnect; Failure to Disconnect

  DURING NORMAL DEVICE REPLACEMENT PROCEDURE, THE LEAD WAS UNABLE TO BE REMOVED FROM THE DEVICE HEADER. THE EVENT WAS RESOLVED BY EXPLANTING AND REPLACING THE DEVICE AFTER CUTTING THE LEAD DURING THE NORMAL DEVICE REPLACEMENT PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15026788 ↗
• InjuryApr 19, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR A FOLLOW UP IN CLINIC WITH A PULSE GENERATOR THAT EXHIBITED FAILURE TO INTERROGATE. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14149213 ↗
• InjuryApr 7, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DIZZINESS AND SHORTNESS OF BREATH. THE PATIENT'S PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.

  Patient problems: Dizziness; Dyspnea

  MAUDE report 14048326 ↗
• InjuryDec 21, 2021Failure to Interrogate; No Pacing; Failure to Interrogate; No Pacing

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BRADYCARDIA, FATIGUE, AND MALAISE. UPON INTERROGATION, IT WAS OBSERVED THAT THE PACEMAKER WAS AT END-OF-SERVICE, AND EXHIBITED A FAILURE TO PACE AND FAILURE TO BE INTERROGATED THROUGH RADIO FREQUENCY (RF) TELEMETRY¿BOTH DUE TO THE DEVICE BEING AT THE END OF ITS EXPECTED BATTERY LIFE. THE PACEMAKER WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Arrhythmia; Discomfort; Fatigue

  MAUDE report 13054188 ↗
• MalfunctionNov 22, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PACEMAKER (PM) EXHIBITED A PACING PROBLEM DUE TO ELECTROCAUTERY USE. THE PM WAS SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858239 ↗
• MalfunctionOct 22, 2021No Pacing; No Pacing

  IT WAS REPORTED THAT THE DEPENDENT PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON DEVICE INTERROGATION, THE PULSE GENERATOR EXHIBITED NO PACING. PROGRAMMING CHANGES WERE MADE AT PREVIOUS FOLLOW UPS THAT DID NOT HELP FIX THE PROBLEM. PROVOCATIVE TESTING WAS PERFORMED, NO ISSUES WERE FOUND. IT WAS SUSPECTED THAT THE DEVICE WAS NOT WORKING. NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE AND WOULD BE CONTINUED TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683399 ↗

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-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-0429-2012 · Sep 23, 2011 · Terminated
  Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0430-2012 · Sep 23, 2011 · Terminated
  Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0298-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
• Z-0296-2007 · Oct 6, 2006 · Terminated
  St. 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 · Terminated
  St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
• Z-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator