Verity® ADx XL SCRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 05414734006712), received between Jun 15, 2018 and Dec 29, 2025 — classified as 19 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (8 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 33 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH POCKET INFECTION. THE PHYSICIAN ELECTED TO EXPLANT THE PACEMAKER SYSTEM. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17102277 ↗
• InjuryApr 17, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEAD REVISION PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING CAUSING PACING INHIBITION. THE RA LEAD WAS CAPPED AND REPLACED ON (B)(6) 2023. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16749230 ↗
• InjuryFeb 28, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456466 ↗
• InjuryJan 3, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT A PATIENT PRESENTED IN CLINIC ON (B)(6) 2022 FOR A ROUTINE FOLLOW UP, WHERE IT WAS NOTED UPON INTERROGATION THAT THEIR PACEMAKER HAD EXPERIENCED PREMATURE BATTERY DEPLETION. THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086262 ↗
• MalfunctionDec 14, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983266 ↗
• MalfunctionNov 4, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  NEW INFORMATION NOTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15733058 ↗
• InjuryJul 11, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THE PATIENT PRESENTED TO THE HOSPITAL FEELING DIZZY. UPON INTERROGATION, IT WAS DETERMINED THE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Dizziness

  MAUDE report 14980951 ↗
• MalfunctionJun 22, 2022Failure to Disconnect; Failure to Disconnect

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-13159. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR THE GENERATOR CHANGE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ALLEGED THAT THE RIGHT VENTRICULAR (RV) LEAD FAILED TO BE REMOVED FROM THE PATIENT'S PACEMAKER. THE RV LEAD AND THE PACEMAKER WERE REPLACED DURING THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14782995 ↗
• InjuryMay 4, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT PATIENT PRESENTED TO EMERGENCY ROOM AFTER EXPERIENCING SYNCOPE AND DYSPNEA. UPON INTERROGATION IT WAS FOUND THAT PATIENT'S PACEMAKER WAS IN BACKUP MODE. IT WAS NOTED THAT THE PACEMAKER WAS AT ELECTIVE REPLACEMENT INDICATOR. IT WAS ALSO NOTED FROM ELECTROCARDIOGRAM THAT PATIENT WAS IN COMPLETE HEART BLOCK. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia; Dyspnea; Syncope/Fainting

  MAUDE report 14281909 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S PACEMAKER POCKET WAS INFECTED. PATIENT'S ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14212377 ↗
• InjuryMar 31, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DIZZINESS. THE DEVICE WAS UNABLE TO BE INTERROGATED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS SUCCESSFULLY INTERROGATED THE NEXT DAY. THE DIZZINESS OF THE PATIENT WAS NOT SUSPECTED TO BE RELATED TO THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966727 ↗
• MalfunctionOct 25, 2021Pacing Asynchronously; Under-Sensing; Pacing Asynchronously; Under-Sensing

  IT WAS REPORTED THAT THE PACEMAKER (PM) WAS UNDER-SENSING LEADING TO FUNCTIONAL LOSS OF CAPTURE AS CITED IN A RESEARCH ARTICLE. THE PATIENT WAS ASYMPTOMATIC. THE PM WAS REPROGRAMMED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12688904 ↗
• InjuryJun 2, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN-CLINIC FOLLOW UP. UPON INTERROGATION OF THE PULSE GENERATOR PREMATURE BATTERY DEPLETION WAS OBSERVED. THE PATIENT WAS SCHEDULED FOR EXPLANT AND THE DEVICE WAS SUCCESSFULLY REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11923558 ↗
• MalfunctionMay 25, 2021Pacemaker Found in Back-Up Mode; Battery Problem; Pacemaker Found in Back-Up Mode; Battery Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE ENTERED BACKUP MODE DUE TO REACHING NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) LEVEL. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL ERI. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881531 ↗
• MalfunctionMar 1, 2021Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT A PATIENT PRESENTED FOR A RADIOFREQUENCY ABLATION PROCEDURE ON (B)(6) 2021. THE FOLLOWING DAY, THE PATIENT'S PACEMAKER WAS FOUND TO BE IN BACKUP OPERATION. IT IS UNKNOWN IF ANY ACTION WAS TAKEN TO ADDRESS THIS ISSUE. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395961 ↗
• InjuryNov 6, 2020Premature Discharge of Battery; Pacemaker Found in Back-Up Mode; Therapy Delivered to Incorrect Body Area; Premature Discharge of Battery; Pacemaker Found in Back-Up Mode; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP IN CLINIC DUE TO DIAPHRAGMATIC STIMULATION ON THE DEVICE. THE PATIENT WAS FEELING UNWELL. THE DEVICE WAS FOUND TO BE IN BACKUP VVI. PREMATURE BATTERY DEPLETION WAS NOTED. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Discomfort; Undesired Nerve Stimulation

  MAUDE report 10800189 ↗
• MalfunctionApr 7, 2020Difficult to Remove; Failure to Disconnect; Difficult to Remove; Failure to Disconnect

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-04721. IT WAS REPORTED THAT THE PATIENT PRESENTED AT A FOLLOW-UP IN CLINIC WITH SYNCOPE. UPON INTERROGATION, THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE. THE PHYSICIAN CAPPED AND REPLACED THE LEAD ON (B)(6) 2020. DURING PROCEDURE, THE RIGHT VENTRICULAR LEAD WAS UNABLE TO BE REMOVED FROM THE HEADER OF THE PACEMAKER. THE PHYSICIAN CUT OUT THE LEAD AND EXPLANTED AND REPLACED THE PACEMAKER. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope

  MAUDE report 9932137 ↗
• InjurySep 18, 2019Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FEELING FAINT. UPON REVIEW, THE PACEMAKER WAS UNABLE TO BE INTERROGATED AND IT WAS DISCOVERED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: Dizziness

  MAUDE report 9084481 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-05081. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RUPTURED IMPLANT POCKET. THE PHYSICIAN REMOVED THE PACEMAKER AND LEAD AND IMPLANTED IT ON THE RIGHT SIDE. THE PATIENT IS STABLE.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 8491443 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2019, THE PATIENT PRESENTED TO THE HOSPITAL FOR FOLLOW- UP AND FOUND THE POCKET WAS SEPARATED CAUSING THE DEVICE SYSTEM TO BE VISIBLE. SUSPECTED EROSION/INFECTION AT THE POCKET SITE. PATIENT WAS ADMITTED ON (B)(6) 2019 AND THE DEVICE WAS REMOVED THE FOLLOWING DAY. THE PATIENT WAS GIVEN ANTIBIOTIC TO CONTROL THE INFECTION AND WAS RECOVERING.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 8380131 ↗
• MalfunctionFeb 17, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE DEVICE WAS IN BACKUP VVI MODE. THE DEVICE WAS RESET AND PROGRAMMED TO NORMAL PACING MODE AFTER CONTACTING TECHNICAL SERVICES. BATTERY LIFE MEASURED GOOD PARAMETERS. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8346509 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE ADVISORY FOR PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ALTHOUGH THERE WAS NO ERI ALERT OR ALLEGATION OF PREMATURE BATTERY DEPLETION, THE DEVICE WAS EXPLANTED PROPHYLACTICALLY. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174707 ↗
• MalfunctionDec 10, 2018Misconnection; Separation Failure; Misconnection; Separation Failure

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLD. THE PATIENT PRESENTED ON (B)(6) 2018 FOR LEAD REVISION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY UNSCREWING THE LEAD FROM THE PULSE GENERATOR. ONCE THE LEAD WAS REMOVED FROM THE DEVICE AND WAS CAPPED ON (B)(6) 2018, A NEW LEAD WAS INSERTED INTO THE DEVICE. HOWEVER, THE SET SCREW WOULD NOT TIGHTEN. THE DEVICE WAS ALSO REMOVED. THE DEVICE AND LEAD WAS REPLACED SUCCESSFULLY. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8146946 ↗
• InjuryOct 18, 2018Failure to Sense; No Pacing; Failure to Sense; No Pacing

  IT WAS REPORTED THAT UPON INTERROGATION, THE ASYMPTOMATIC PATIENT'S PACEMAKER EXHIBITED NO PACING AND NO SENSING. ON (B)(6) 2018, THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7982279 ↗

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