Verity™ ADx XL DR (REF 5357M/S)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734006842), received between Nov 10, 2020 and Oct 5, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Interrogate” (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 18, 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.

• MalfunctionOct 5, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC WITH A DIAGNOSTIC ANOMALY NOTED ON THE PATIENT'S PACEMAKER. NO INTERVENTION WAS TAKEN TO ADDRESS THE DIAGNOSTIC ISSUE AND THE PACEMAKER WAS EXPLANTED AND REPLACED ELECTIVELY ON 15 SEP 2023. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17882895 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INFECTION. THE PATIENT HAD THEIR ENTIRE PACEMAKER SYSTEM REMOVED ON (B)(6) 2020. PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 11033999 ↗
• InjuryNov 10, 2020Failure to Interrogate; Pacing Intermittently; Failure to Interrogate; Pacing Intermittently

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM AND WAS INTERMITTENTLY PACING. WHEN ATTEMPTING TO INTERROGATE THE DEVICE, AN ERROR MESSAGE APPEARED ON THE PROGRAMMER. IT WAS SUSPECTED THAT THE DEVICE WAS AT END OF LIFE, CAUSING THE INTERMITTENT PACING. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10814704 ↗

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-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-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 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