Quartet™ 1457QRecalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 05414734510172), received between Aug 20, 2018 and Aug 24, 2026 — classified as 5 deaths, 70 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (50 reports).

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 86 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Failure to Capture

  It was reported that the patient presented for a follow-up in clinic. Interrogation revealed that the left ventricular (LV) lead exhibited loss of capture. The LV lead was subsequently explanted and replaced. The patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50398655 ↗
• InjuryAug 13, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient presented in the emergency room. It was noted that the left ventricular (LV) lead failed to capture. X-ray and fluoroscopy revealed that the LV lead had dislodged. The LV lead was explanted and replaced. The patient remained in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231862 ↗
• DeathMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25086789 ↗
• DeathApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DECEASED ON AN UNKNOWN DATE. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035601 ↗
• InjuryApr 2, 2026Failure to Capture

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH LOSS OF CAPTURE NOTED ON THE PATIENT'S LEFT VENTRICULAR LEAD. THE LEAD WAS EXPLANTED ON (B)(6) 2026. THE PATIENT WAS DISCHARGED WITHOUT REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767373 ↗
• MalfunctionNov 18, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED PROCEDURE TO UPGRADE FROM A DUAL-CHAMBER PACEMAKER TO A CRT-P SYSTEM. DURING THE PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD COULD NOT BE ADVANCED BEYOND THE TIP OF THE DELIVERY CATHETER. MULTIPLE ATTEMPTS WERE MADE BY REPLACING THE LEAD AND CATHETER, BUT ALL WERE UNSUCCESSFUL. ULTIMATELY, THE PHYSICIAN DECIDED TO CHANGE THE APPROACH TO CONDUCTION SYSTEM PACING, WHICH WAS COMPLETED SUCCESSFULLY. THE PATIENT REMAINED STABLE AND ASYMPTOMATIC THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585204 ↗
• InjuryNov 17, 2025Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED POST-PROCEDURE, AFTER LEAVING THE PROCEDURE ROOM. IT WAS OBSERVED THAT THE LEFT VENTRICULAR (LV) LEAD WAS DISLODGED. DISLODGEMENT WAS CONFIRMED VIA CHEST X-RAY. IT WAS ALSO NOTED THAT THE LEAD EXHIBITED LOSS OF CAPTURE. THE LV LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD ON (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572662 ↗
• MalfunctionJul 6, 2025Failure to Disconnect; Device Dislodged or Dislocated; Failure to Disconnect; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN UPGRADE PROCEDURE. DURING THE LASER LEAD EXTRACTION OF THE RIGHT VENTRICULAR LEAD, IT WAS NOTED THAT THE RIGHT ATRIAL AND THE LEFT VENTRICULAR LEADS WERE STUCK TOGETHER AND DISLODGED AS CONFIRMED VIA FLUOROSCOPY. THE LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409193 ↗
• InjuryMar 21, 2025Failure to Capture; Failure to Capture

  RELATED MANUFACTURER REFERENCE NUMBER:2017865-2025-28068. IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT PATIENT'S LEFT VENTRICULAR (LV) AND ATRIAL LEAD EXHIBITED LOSS OF CAPTURE. THE LV LEAD WAS EXPLANTED AND REPLACED. THE ATRIAL LEAD WAS REPOSITIONED ON (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665526 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-00288. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-00292. IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR LEAD AND RIGHT ATRIAL LEAD EXPLANTED DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT.

  Patient problems: Unspecified Infection

  MAUDE report 21076849 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POCKET INFECTION AND EROSION. THE IMPLANT SITE WAS RED. UPON FURTHER INVESTIGATION VIA TRANS-ESOPHAGEAL ECHOCARDIOGRAM, POSSIBLE VEGETATION WAS NOTED ON AN UNIDENTIFIED LEAD. THE ENTIRE PACEMAKER SYSTEM WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 19761065 ↗
• InjuryDec 22, 2023Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  DURING FOLLOW-UP, A LOSS OF CAPTURE WAS OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD DUE TO DISLODGEMENT. THE EVENT WAS RESOLVED BY CAPPING AND REPLACING THE LV LEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387195 ↗
• InjuryDec 13, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED, THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN THE CLINIC. UPON INTERROGATION, IT WAS NOTED, THAT THE LEFT VENTRICULAR (LV) LEAD WAS FAILING TO CAPTURE. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316254 ↗
• InjuryOct 10, 2023Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR UNRELATED MATTER. UPON CHEST X-RAY, IT WAS FOUND THAT THE LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. INTERROGATION WAS PERFORMED AND NOTED NO CAPTURE ON THE LV LEAD. PROGRAMMING CHANGES WERE MADE TO DEACTIVATE THE LV LEAD. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903324 ↗
• InjuryJun 13, 2023Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW-UP ONE DAY POST-IMPLANT. A DEVICE INTERROGATION REVEALED LOSS OF CAPTURE EXHIBITED BY THE LEFT VENTRICULAR LEAD. A SUBSEQUENT X-RAY REVEALED THAT THE LEAD HAD DISLODGED FROM THE ORIGINAL IMPLANT POSITION. THE PATIENT WAS SCHEDULED FOR REPLACEMENT AND THE LEAD WAS EXPLANTED. THE PATIENT WAS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119004 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-22310, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-22311, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-22312, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-22314. IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC WITH SEPSIS DUE TO AN SYSTEM INFECTION. ALL THE LEADS OF THE SYSTEM WERE FOUND TO HAVE VEGETATION. SURGICAL INTERVENTION WAS TAKEN TO REMOVE THE SYSTEM ON (B)(6) 2023. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Unspecified Infection

  MAUDE report 17065721 ↗
• InjuryDec 15, 2022Capturing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS DISCOVERED THE LEFT VENTRICULAR LEAD EXHIBITED AN INCREASED CAPTURE THRESHOLD. IMAGING CONFIRMED THE LEFT VENTRICULAR LEAD HAD DISLODGED. THE LEFT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992755 ↗
• MalfunctionNov 29, 2022Low impedance; Low impedance

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE LEFT VENTRICULAR LEAD EXHIBITED LOW PACING IMPEDANCE. THE LEAD WAS SUCCESSFULLY REPROGRAMMED. THE PATIENT WAS STABLE AND ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880516 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-44359, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-44361, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-44362. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC UPON DEVELOPING AN INFECTION. THE PATIENT'S FULL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WAS EXPLANTED AND REPLACED. THE PATIENT'S HEALTH STATUS WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15739171 ↗
• InjuryAug 12, 2022Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-17451. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON REVIEW, THE LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE. THE PATIENT PRESENTED TO A SCHEDULED LEAD REVISION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE LV LEAD WAS DISLODGED AND THAT THE RIGHT VENTRICULAR(RV) LEAD EXHIBITED DECREASED R-WAVES. THE RV LEAD COULD NOT BE RE-POSITIONED AS THE HELIX WOULD NOT RETRACT NOR EXTEND. THE RV AND LV LEADS WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218132 ↗
• InjuryJul 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE LEFT VENTRICULAR LEAD HAD DISLODGED. DIAGNOSTIC IMAGING CONFIRMED DISLODGEMENT. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE AND ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099585 ↗
• InjuryJun 1, 2022Capturing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. DURING INTERROGATION, IT WAS FOUND THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASE IN CAPTURE THRESHOLD. CHEST X-RAY WAS PERFORMED AND CONFIRMED LV LEAD DISLODGEMENT. THE LV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2022. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14567547 ↗
• MalfunctionApr 4, 2022Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-07075, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-07076. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED DISLODGEMENT ON THE LEFT VENTRICULAR (LV) LEAD AND ATRIAL LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE LV AND ATRIAL LEAD. THE REPLACEMENT LV LEAD WAS FOUND TO HAVE A LOOSE CONNECTOR PIN AND WAS UNABLE TO BE IMPLANTED. A NEW LV LEAD WAS SUCCESSFULLY IMPLANTED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14005549 ↗
• InjuryApr 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-07076, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-07077. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED DISLODGEMENT ON THE LEFT VENTRICULAR (LV) LEAD AND ATRIAL LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE LV AND ATRIAL LEAD. THE REPLACEMENT LV LEAD WAS FOUND TO HAVE A LOOSE CONNECTOR PIN AND WAS UNABLE TO BE IMPLANTED. A NEW LV LEAD WAS SUCCESSFULLY IMPLANTED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14005394 ↗
• InjuryFeb 25, 2022Capturing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-PATIENT IN HOSPITAL. DURING INTERROGATION, IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD WAS FOUND DISLODGED AND CAUSING FAILURE TO CAPTURE. THE REPORTED LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2022 DURING A GENERATOR CHANGEOUT PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599102 ↗