Verity® ADx XL SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 05414734006767), received between Jun 18, 2018 and Jun 14, 2026 — classified as 43 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (9 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 81 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJan 16, 2024Over-Sensing; No Pacing; Over-Sensing; No Pacing

  THE PATIENT PRESENTED IN-CLINIC AFTER EXPERIENCING AN EPISODE OF SYNCOPE AND FALL. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND NOTED NOISE RESULTING IN OVERSENSING AND PACING INHIBITION WAS THE LIKELY CAUSE OF THE EVENT. TECHNICAL SUPPORT RECOMMENDED FURTHER INVESTIGATION VIA PROVOCATIVE TESTING, HOWEVER, NO INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Syncope/Fainting

  MAUDE report 18522346 ↗
• MalfunctionOct 27, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, UNDERSENSING WAS NOTED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021919 ↗
• InjuryOct 17, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952959 ↗
• MalfunctionMay 25, 2023Incorrect Measurement; Battery Problem; Incorrect Measurement; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM ABBOTT TECHNICAL SUPPORT INDICATED THE HIGH BATTERY IMPEDANCE IS DUE TO A DIAGNOSTIC ANOMALY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004814 ↗
• InjuryMay 23, 2023Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, THE DEVICE WAS FOUND TO BE IN BACKUP VVI (BVVI) MODE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, HOWEVER, THE DEVICE WAS UNABLE TO BE SUCCESSFULLY REPROGRAMMED. 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 16984747 ↗
• MalfunctionApr 28, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS DISCOVERED THE PACEMAKER'S LONGEVITY REMAINED THE SAME AS A DEVICE CHECK PERFORMED (B)(6) 2022. NO CHANGES OR INTERVENTIONS WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16838475 ↗
• InjuryApr 25, 2023Pacemaker Found in Back-Up Mode; Environmental Compatibility Problem; Pacemaker Found in Back-Up Mode; Environmental Compatibility Problem

  FOLLOWING A MRI PROCEDURE, THE DEVICE WAS OBSERVED TO BE IN BACKUP MODE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807023 ↗
• MalfunctionApr 3, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT A PACING OUTPUT RATE ISSUE WAS OBSERVED ON THE DEVICE. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16664462 ↗
• InjuryJan 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-02488. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A FOLLOW-UP ON (B)(6) 2022. UPON EXAMINATION, IT WAS NOTED THAT THE PATIENT'S PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2022 FOR AN UNREPORTED INDICATION. THE PHYSICIAN CAPPED AND REPLACED RIGHT VENTRICULAR (RV) LEAD AS WELL IN THE SAME PROCEDURE FOR AN UNREPORTED INDICATION. THE PATIENT CONDITION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195737 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS AND LIGHTHEADEDNESS.

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 15451998 ↗
• MalfunctionAug 25, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THE PATIENT PRESENTED PRIOR TO AN UNRELATED PROCEDURE. A DEVICE CHECK BEFORE THE PROCEDURE REVEALED THE PACEMAKER COULD NOT BE INTERROGATED. POST-PROCEDURE, THE PACEMAKER COULD BE INTERROGATED AS NORMAL. THE SUSPECTED CAUSE WAS ELECTROMAGNETIC INTERFERENCE (EMI). THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298515 ↗
• InjuryJun 28, 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. THE DEVICE REPLACEMENT IS ANTICIPATED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841027 ↗
• InjuryMay 10, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED PREMATURE BATTERY DEPLETION ON THE PACEMAKER. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE PACEMAKER. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14348431 ↗
• InjuryApr 5, 2022Premature Discharge of Battery; Incorrect Measurement; Premature Discharge of Battery; Incorrect Measurement

  DURING AN IN CLINIC FOLLOW-UP, THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) VOLTAGE LEVEL. PREMATURE BATTERY DEPLETION WAS SUSPECTED TO BE THE CAUSE OF THE EVENT. ADDITIONALLY, THE PHYSICIAN ALLEGED THE ERI ALERT WAS FALSELY TRIGGERED AS THE REMAINING VOLTAGE WAS NOT LOW ENOUGH TO BE CONSIDERED ERI. 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 14015176 ↗
• MalfunctionDec 28, 2021Failure to Disconnect; Failure to Disconnect

  DURING A DEVICE REPLACEMENT PROCEDURE DUE TO NORMAL BATTERY DEPLETION, THE PHYSICIAN ATTEMPTED TO UNSCREW THE HEADER SET SCREW BUT WAS UNSUCCESSFUL. THE PHYSICIAN RESOLVED THE EVENT BY CUTTING THE OLD LEAD AND EXPLANTING THE DEVICE. A NEW DEVICE AND LEAD WERE THEN IMPLANTED. NO MALFUNCTION WAS ALLEGED AGAINST THE LEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13099984 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURER REFERENCE NUMBER: 2017865-2021-36663. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH AN INFECTION. THE PHYSICIAN DOES NOT ALLEGE ABBOTT DEVICES OR ANY PROCEDURE INVOLVING THE ABBOTT DEVICES, CAUSED, OR CONTRIBUTED TO THE INFECTION. ON (B)(6) 2021, THE PHYSICIAN EXPLANTED THE PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD AND IMPLANTED A TEMPORARY PACEMAKER. THE PATIENT CONDITION WAS STABLE BEFORE, DURING, AND AFTERWARDS.

  Patient problems: Unspecified Infection

  MAUDE report 12821535 ↗

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-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-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-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator