Verity™ ADx XL DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05414734006811), received between Jul 13, 2018 and Sep 4, 2026 — classified as 8 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Failure to Interrogate” (3 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 20 most recent of 20 reports, 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 ↗
• MalfunctionNov 2, 2023Difficult to Remove; Difficult to Remove

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-51484. DURING A ROUTINE DEVICE EXCHANGE PROCEDURE, THE SET SCREWS COULD NOT BE LOOSENED IN ORDER TO REMOVE THE RIGHT VENTRICULAR (RV) LEAD FROM THE HEADER OF THE DEVICE. IN ADDITION, INSULATION DAMAGE WAS NOTED ON RV LEAD. THE RV LEAD WAS CAPPED, AND A REPLACEMENT DEVICE AND RV LEAD WERE IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18056466 ↗
• InjuryNov 29, 2022Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED HIGH CAPTURE THRESHOLDS. THE PACEMAKER WAS EXPLANTED AND PATIENT'S CONDITION WAS NOTED TO BE STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875689 ↗
• InjuryAug 24, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE EMERGENCY ROOM HAVING NEAR SYNCOPE EPISODES. UPON INTERROGATION, IT WAS NOTED THAT THE PACEMAKER EXHIBITED FAILURE TO CAPTURE AND HAD RESULTED IN SYNCOPE EPISODES IN THE PAST. PROGRAMMING CHANGES WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 15283121 ↗
• MalfunctionMay 21, 2022Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE PACEMAKER CHANGE. DURING IMPLANT, THE PHYSICIAN WAS UNABLE TO UNSCREW THE CONNECTOR PIN OF THE VENTRICULAR LEAD FROM THE PACEMAKER HEADER. SEVERAL ATTEMPTS WERE MADE BUT THERE WAS NO ROTATION OF THE SCREW ON THE PACEMAKER HEADER. THERE WAS NO COMPLAINT ON THE LEAD ONLY ON THE PACEMAKER. THE LEAD WAS CAPPED. BOTH THE PACEMAKER AND LEAD WERE REPLACED SUCCESSFULLY. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466602 ↗
• MalfunctionMar 1, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PACEMAKER EXHIBITED POST PACED T WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637236 ↗
• MalfunctionNov 18, 2021Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE PULSE GENERATOR CHANGE. DURING THE PROCEDURE, THE DEVICE THE PHYSICIAN HAD DIFFICULTY DISCONNECTING THE DEVICE FROM THE LEADS. MULTIPLE TORQUE DRIVERS WERE APPLIED TO THE SETSCREW. THE PHYSICIAN RESORTED TO CUTTING THE LEADS FREE THEM FROM THE DEVICE HEADER. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. THE PATIENT WAS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12837269 ↗
• MalfunctionSep 7, 2021Failure to Interrogate; Pacemaker Found in Back-Up Mode; Failure to Interrogate; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. THE PACEMAKER WAS NOTED TO BE IN BACKUP VVI MODE AND COULD NOT BE INTERROGATED. NO DEVICE INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434348 ↗
• InjuryMar 1, 2021Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT UPON INTERROGATION OF THE DEVICE, IT WAS FOUND TO BE AT BACKUP VVI MODE. THE DEVICE WILL BE EXPLANTED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11393021 ↗
• MalfunctionNov 6, 2020Data Problem; Data Problem

  DURING A CLINIC FOLLOW-UP, THE DEVICE RECEIVED AN ERROR MESSAGE WHEN MEASURING THE LEAD PARAMETER CHECKS. TECHNICAL SUPPORT WAS CONTACTED, BUT NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10802857 ↗
• MalfunctionSep 9, 2020Misconnection; Misconnection

  DURING A DEVICE EXCHANGE PROCEDURE TO ADDRESS NORMAL BATTERY DEPLETION, THE VENTRICULAR LEAD COULD NOT BE REMOVED FROM THE HEADER OF THE DEVICE AFTER REPEATED ATTEMPTS TO LOOSEN THE SET SCREWS. THE LEAD WAS CUT AND CAPPED SO THAT THE DEVICE COULD BE EXPLANTED, AND A NEW DEVICE AND LEAD WERE IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10512089 ↗
• MalfunctionDec 5, 2019Incorrect Measurement; Incorrect Measurement

  DURING A FOLLOW-UP IN CLINIC, THE REMAINING ESTIMATED LONGEVITY WAS LOWER THAN EXPECTED. TECHNICAL SUPPORT WAS CONTACTED, AND THE LONGEVITY ESTIMATE WAS DETERMINED TO BE FALSE. THE DEVICE WILL BE REPLACED AT A LATER DATE AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9419330 ↗
• InjurySep 26, 2019Failure to Interrogate; Failure to Interrogate

  DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS UNABLE TO BE INTERROGATED WITH SEVERAL PROGRAMMERS. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9125652 ↗
• MalfunctionMay 15, 2019No Pacing; No Pacing

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR CHANGE, THE PACEMAKER STOPPED PACING DUE TO USE OF ELECTROCAUTERY. THE PATIENT EXPERIENCED BRADYCARDIA. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT WAS STABLE.

  Patient problems: Bradycardia

  MAUDE report 8613584 ↗
• InjuryApr 2, 2019Premature Discharge of Battery; Premature Discharge of Battery

  ONE DAY FOLLOWING IMPLANT, PREMATURE BATTERY DEPLETION WAS REPORTED. THE DEVICE WAS EXPLANTED AND REPLACED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8472929 ↗
• InjuryMar 6, 2019Premature Discharge of Battery; Failure to Interrogate; Pacing Inadequately; Premature Discharge of Battery; Failure to Interrogate; Pacing Inadequately

  DURING A FOLLOW-UP IN CLINIC, THE DEVICE COULD NOT BE INTERROGATED AND WAS PACING INADEQUATELY. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR DEVICE REPLACEMENT, AND DURING THE HOSPITAL STAY THE PATIENT HAD FALLEN DUE TO AN ASYSTOLE EPISODE. A TEMPORARY PACER WAS USED UNTIL THE DEVICE COULD BE REPLACED. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Syncope

  MAUDE report 8396259 ↗
• MalfunctionFeb 12, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  DURING FOLLOW-UP, THE DEVICE WAS INTERROGATED AND FALSE ERI MESSAGE WAS DELIVERED. THE DEVICE'S BATTERY ICON SHOWS FULLY CHARGED. TECHNICAL SUPPORT WAS CONTACTED AND THE PHYSICIAN WILL TO INTERROGATE THE DEVICE AGAIN AND CLEAR THE ERI MESSAGE AT PATIENT'S NEXT FOLLOW-UP. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8330918 ↗
• InjuryJan 11, 2019Premature Discharge of Battery; Pacemaker Found in Back-Up Mode; Premature Discharge of Battery; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE PACEMAKER EXHIBITED BACKUP VVI DUE TO PREMATURE BATTERY DEPLETION. V PULSE AMPLITUDE WAS NOTED TO BE GREATER THAN 4 V. THE PHYSICIAN BELIEVES THAT THE LEAD WEAR CAUSED THE DEVICE TO GO INTO BACKUP VVI. BRADYCARDIA WAS NOTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE RV LEAD WAS MADE INACTIVE AND LEFT IN THE PATIENT'S BODY. A NEW RV LEAD WAS IMPLANTED SUCCESSFULLY. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: Bradycardia

  MAUDE report 8242593 ↗
• MalfunctionDec 18, 2018Data Problem; Data Problem

  DURING A FOLLOW-UP, THE ESTIMATED BATTERY LONGEVITY ON THE DEVICE DECREASED SIGNIFICANTLY. THE DEVICE WAS RE-INTERROGATED AND THE ESTIMATED LONGEVITY WAS NORMAL. NO FURTHER INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174486 ↗
• MalfunctionJul 13, 2018Misconnection; Misconnection

  DURING DEVICE REPLACEMENT DUE TO NORMAL ERI, THE SET SCREW WAS UNABLE TO BE WITHDRAWN DUE TO BEING STRIPPED. THE ISSUE WAS RESOLVED BY CUTTING THE LEAD AND REPLACING THE DEVICE AND LEAD. THE PATIENT WAS IN STABLE CONDITION AND EXPERIENCED NO ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7685889 ↗

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-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• 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-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