Verity™ ADx XL SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734006774), received between Jan 22, 2019 and Jun 12, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Pacemaker Found in Back-Up Mode” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2023Difficult to Remove; Difficult to Remove

  DURING EXPLANT DUE TO NORMAL BATTERY DEPLETION, IT WAS REPORTED THAT THE TORQUE WRENCH COULD NOT REMOVE FROM THE SET SCREW FROM THE HEADER OF THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114068 ↗
• MalfunctionAug 22, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED BACKUP MODE ON THE PACEMAKER (PM). NO CHANGES OR INTERVENTION WERE REPORTED. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272085 ↗
• MalfunctionApr 4, 2022Failure to Capture; Pacemaker Found in Back-Up Mode; Therapy Delivered to Incorrect Body Area; Failure to Capture; Pacemaker Found in Back-Up Mode; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH POCKET STIMULATION. UPON INTERROGATION, IT WAS FOUND THAT THE PACEMAKER WENT INTO BACKUP OPERATION AND EXHIBITED FAILURE TO CAPTURE. NO INTERVENTION WAS PERFORMED AS THE PACEMAKER FAILED TO BE RESTORED. PATIENT CONDITION WAS STABLE AND THE PATIENT WOULD CONTINUE TO BE MONITORED.

  Patient problems: Discomfort

  MAUDE report 14002236 ↗
• MalfunctionMay 30, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  DURING FOLLOW-UP, FALSE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS NOTED ON THE DEVICE. THE DEVICE WAS REPROGRAMMED AND RESTORED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8655345 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A ROUTINE FOLLOW UP, POCKET INFECTION WAS OBSERVED. THE PRIMARY AND SECONDARY CAUSE OF INFECTION WAS UNKNOWN. THE DEVICE WAS EXPLANTED. THERE IS NO KNOWN ALLEGATION FROM THE HEALTH CARE PROFESSIONAL THAT THE INFECTION WAS RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 8269354 ↗

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-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-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-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