QUADRA ALLURE MP™ PM3160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734509084), received between Aug 23, 2022 and Jan 24, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

5 other recalls cover devices cleared under the same FDA submission (P030035); 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.

• MalfunctionJan 24, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2024-01749. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE PROCEDURE DUE TO NORMAL BATTERY DEPLETION. DURING THE PROCEDURE, IT WAS NOTED THAT THE CHRONIC LEFT VENTRICULAR (LV) LEAD EXHIBITED AN ELEVATED CAPTURE THRESHOLD. THE PHYSICIAN INTENDED TO REPLACE THE LV LEAD. DURING THE REPLACEMENT, IT WAS FOUND THAT THE GUIDEWIRE WAS FAILING TO BE REMOVED FROM THE NEW LV LEAD. AN ADDITIONAL ATTEMPT TO REMOVE THE GUIDEWIRE DAMAGED THE NEW LV LEAD. THUS, NO NEW LV LEAD WAS IMPLANTED. PROGRAMMING CHANGES WERE MADE ON THE CHRONIC LV LEAD TO ADDRESS HIGH CAPTURE THRESHOLD. WHEN THE PHYSICIAN ATTEMPTED TO CONNECT THE CHRONIC LV LEAD TO THE NEW PACEMAKER, IT WAS FOUND THAT THE PACEMAKER SETSCREW EXHIBITED LOOSE CONNECTIONS. THE PACEMAKER WAS NOT USED. THE PHYSICIAN CONTINUED WITH SECOND NEW PACEMAKER AND COMPLETED THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18568151 ↗
• InjuryJul 19, 2023Defective Device; Defective Device

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-36102 IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED FAILURE TO CAPTURE, FAILURE TO SENSE AND LOW PACING IMPEDANCE WHICH MAY BE DUE TO HEADER ANOMALY ON THE PACEMAKER. THE PACEMAKER AND THE RV LEAD WERE EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17355920 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-21222; RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-21223; RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-21225. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW-UP WITH DISCHARGE AT THE IMPLANT SITE OF THE PULSE GENERATOR. THE GENERATOR, RIGHT ATRIAL, RIGHT VENTRICULAR, AND LEFT VENTRICULAR LEADS WERE EXPLANTED DUE TO POCKET INFECTION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 15277994 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030035. 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.