Allure Quadra™ PM3140Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05414734507899), received between Aug 2, 2018 and Jan 12, 2026 — classified as 21 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (7 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT AFTER INSERTING THE LEAD, THE SET SCREW OF THE RIGHT VENTRICULAR PORT AT THE PACEMAKER'S HEADER WAS UNABLE TO BE TIGHTENED. THE PACEMAKER WAS NOT USED, AND A NEW PACEMAKER WAS IMPLANTED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032915 ↗
• MalfunctionSep 17, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE ATRIAL LEAD COULD NOT BE CONNECTED TO THE PACEMAKER (PM). THE PHYSICIAN ELECTED TO NOT USED THE PM. FINALLY, THE SAME ATRIAL LEAD WAS CONNECTED TO THE NEW PM SUCCESSFULLY. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070240 ↗
• InjurySep 10, 2025Adverse 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 INITIAL PACEMAKER IMPLANT PROCEDURE. IT WAS NOTED THAT DURING POCKET SUTURING, THE PATIENT HAD AN ARRYTHMIA WHICH REQUIRED ANTI-TACHYCARDIA PACING TO TERMINATE IT. THE PACEMAKER WAS NOT IMPLANTED, AND THE POCKET WAS REOPENED TO IMPLANT AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INSTEAD ON (B)(6) 2025. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 23016939 ↗
• MalfunctionMar 18, 2025Loose or Intermittent Connection; Defective Device; Loose or Intermittent Connection; Defective Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR ROUTINE IMPLANT OF THE PULSE GENERATOR. DURING THE PROCEDURE THE PHYSICIAN ATTEMPTED TO CONNECT THE GENERATOR TO A LEAD WITH A TORQUE WRENCH. HOWEVER, THE WRENCH WAS UNABLE TO ENGAGE THE SET SCREW. THE PROCEDURE WAS COMPLETED WITH USE OF A REPLACEMENT DEVICE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21628277 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD WOUND DEHISCENCE AND INFECTION. ACCORDING TO THE PHYSICIAN, THE INFECTION WAS DUE TO DUE TO LONG-TERM USE OF ANTICOAGULANTS COMBINED WITH DIABETES. THE ENTIRE PACEMAKER SYSTEM WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 21078585 ↗
• InjuryOct 8, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT PATIENT PRESENTED FOR SCHEDULED PROCEDURE. PRIOR TO PROCEDURE, IT WAS NOTED THAT PACEMAKER'S BATTERY WAS EXHAUSTED IN ADVANCE. THE PACEMAKER WAS EXCHANGED AND REPLACED WITH NEW DEVICE. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397018 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC DUE TO AN ERODED DEVICE POCKET. THE ENTIRE PACEMAKER (PM) SYSTEM WAS EXPLANTED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Pocket Erosion

  MAUDE report 18148527 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-24888 RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-24889 RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-24890 IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON REVIEW IT DISCOVERED THAT THE PACEMAKER AND LEADS HAD ERODED. THE PHYSICIAN CONFIRMED THAT THERE WAS AN INFECTION. THE ENTIRE SYSTEM WAS EXPLANTED, AND A WOUND DEBRIDEMENT SURGERY WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 17243465 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REMAINING BATTERY LONGEVITY WAS OVERESTIMATED. THE DEVICE WAS EXPLANTED AND REPLACED PRIOR TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) VOLTAGE LEVEL. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17118227 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMAINING BATTERY LONGEVITY WAS OVERESTIMATED. THE DEVICE WAS EXPLANTED AND REPLACED PRIOR TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) VOLTAGE LEVEL. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17109849 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REMAINING BATTERY LONGEVITY WAS OVERESTIMATED. THE DEVICE WAS EXPLANTED AND REPLACED PRIOR TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) VOLTAGE LEVEL. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070744 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REMAINING BATTERY LONGEVITY WAS OVERESTIMATED. THE DEVICE WAS EXPLANTED AND REPLACED PRIOR TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) VOLTAGE LEVEL. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070561 ↗
• InjuryApr 10, 2023Premature Discharge of Battery; Incorrect Measurement; Premature Discharge of Battery; Incorrect Measurement

  DURING AN IN-CLINIC FOLLOW-UP, A RAPID DROP IN BATTERY LONGEVITY WAS OBSERVED. PREMATURE BATTERY DEPLETION WAS SUSPECTED. DEVICE REPLACEMENT IS ANTICIPATED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707631 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-10199, 2017865-2023-10200, 2017865-2023-10201. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH REDNESS AND SWELLING DUE TO POCKET INFECTION AT THE DEVICE SITE. WHEN THE PHYSICIAN CLEANED THE POCKET, THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE BROKEN. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 16394219 ↗
• MalfunctionFeb 7, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE PROCEDURE FOR ELECTIVE REPLACEMENT INDICATOR. DURING THE PROCEDURE, IT WAS NOTED THAT THE PACEMAKER HEADER WAS FAILING TO CONNECT TO THE LEAD. THE PACEMAKER WAS NOT USED. THE PHYSICIAN CONTINUED WITH SECOND PACEMAKER AND COMPLETED THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16309978 ↗
• InjuryDec 23, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  DURING AN IN CLINIC FOLLOW-UP, UPON INTERROGATION IT WAS NOTED THE DEVICE WAS IN BACK UP MODE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16043004 ↗
• InjuryMay 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-10579, 2017865-2022-10580, 2017865-2022-10581. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DISCOMFORT, PAIN, ITCHING, AND CAPSULARY ULCERATION DURING FOLLOW-UP IN CLINIC. THE IMPLANTED DEVICE POCKET WAS NOTED TO BE RED, SWOLLEN, AND RUPTURED. THE PHYSICIAN EXPLANTED THE SYSTEM ¿ PACEMAKER, RIGHT VENTRICULAR LEAD, LEFT VENTRICULAR LEAD, AND ATRIAL LEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Discomfort; Unspecified Infection; Wound Dehiscence

  MAUDE report 14467572 ↗
• InjuryJul 13, 2021Premature Discharge of Battery; Premature Discharge of Battery

  NEW INFORMATION RECEIVED NOTES THAT THE PACEMAKER WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163257 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-25052. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-25053. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-25055. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC DUE TO DISCOMFORT AT THEIR DEVICE POCKET. THE PHYSICIAN DETERMINED THE POCKET TO BE INFECTED. THE PHYSICIAN EXPLANTED THE PATIENT'S PACEMAKER AND ALL LEADS. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 12124982 ↗
• InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-19971. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH A POCKET INFECTION AND EROSION WITH THEIR LEFT VENTRICULAR (LV) LEAD VISIBLE. THE PHYSICIAN EXPLANTED AND REPLACED THE PATIENT'S SYSTEM. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 11903884 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-13534. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-13536. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO CAPSULAR INFECTION AND RUPTURE. ON (B)(6) 2021, THE PACEMAKER AND TWO LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 11606404 ↗
• MalfunctionNov 20, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT AN EPISODE OF HIGH VENTRICULAR RATE (HVR) WAS OBSERVED ON THE DEVICE. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10880597 ↗
• InjuryJun 13, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTED PACEMAKER REACHED ERI IN 5 YEARS. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

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

  MAUDE report 10151425 ↗
• MalfunctionMay 4, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. INTERROGATION OF THE PACEMAKER REVEALED A DIAGNOSTICS ANOMALY, IT SHOWED AN INCREASE IN BATTERY CURRENT AND THE CURRENT DROPPED AFTER REPROGRAMMING THE DEVICE. A WEEK LATER THE DEVICE WAS CHECKED AGAIN, AND IT WAS NOTED THAT THE BATTERY CURRENT RETURNED TO NORMAL VALUE. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10022676 ↗
• InjuryFeb 10, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION. THE PACEMAKER WAS EXPLANTED AND REPLACED ON (B)(6) 2020. THE PATIENT WAS STABLE POST PROCEDURE.

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

  MAUDE report 9689755 ↗

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-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-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.