Verity™ ADx XL VDR (REF 5456i)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734010474), received between Jun 13, 2018 and Aug 10, 2022 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem: High Impedance” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-17045. IT WAS REPORTED THAT THE PATIENT PASSED AWAY. UPON INVESTIGATION, A DECREASE IN THE PACING IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. HOWEVER, THERE WAS NO INDICATION FROM A HEALTHCARE PROFESSIONAL THAT AN ABBOTT DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. FURTHER INFORMATION WAS REQUESTED, BUT HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201145 ↗
• MalfunctionSep 17, 2020Battery Problem: High Impedance; Battery Problem: High Impedance

  DURING A REMOTE FOLLOW-UP, INCREASED BATTERY IMPEDANCE WAS OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED A FIRMWARE DOWNLOAD TO RESOLVED THE EVENT. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10551363 ↗
• MalfunctionJun 13, 2018Data Problem; Data Problem

  DURING FOLLOW-UP, AN INCORRECT BATTERY IMPEDANCE MEASUREMENT WAS OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING, WHICH WAS PERFORMED IN ORDER TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7599197 ↗

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-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-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