Quartet™ 1457Q-86Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,061 adverse event reports that list this exact device (DI 05414734510189), received between Jun 15, 2018 and Sep 29, 2026 — classified as 21 deaths, 656 injuries, 384 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (544 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 1,061 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High impedance; Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941363 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with infection and was tested positive for bacteremia. The physician stated that the infection was not caused by Abbotts' devices. The patient's implantable cardioverter-defibrillator, the right atrial lead, the right ventricular lead and the left ventricular lead were explanted due to the infection. The patient was stable throughout.

  Patient problems: Unspecified Infection

  MAUDE report 50910624 ↗
• InjurySep 23, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874399 ↗
• MalfunctionSep 18, 2026Failure to Disconnect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831567 ↗
• InjurySep 14, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient presented for a routine follow-up one day after the implant procedure. Upon evaluation, the left ventricular (LV) lead exhibited failure to capture. A chest X-ray revealed that the LV lead had dislodged. The LV lead was explanted and replaced. The patient remained in stable condition throughout the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50749925 ↗
• InjurySep 10, 2026Device Dislodged or Dislocated

  It was reported during in clinic follow up that the left ventricular lead had dislodged. Chest x-ray confirmed dislodgement. The product was explanted and successfully replaced. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721148 ↗
• InjurySep 7, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50646564 ↗
• InjuryAug 21, 2026Failure to Capture; Over-Sensing; Device Dislodged or Dislocated

  It was reported that the patient presented for a follow-up in clinic. X-ray revealed that the left ventricular (LV) had dislodged. Interrogation prior to the revision procedure revealed that the LV lead was sensing the atrial signals and failed to capture. The LV lead was capped and replaced on (b)(6) 2026. No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360587 ↗
• InjuryAug 20, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient presented for an explant procedure. Prior to the procedure, it was noted that the left ventricular (LV) lead had dislodged and exhibited failure to capture. The dislodgement of the LV lead was verified by X-ray and fluoroscopy. The LV lead was explanted and replaced. The patient was in stable condition throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50338982 ↗
• InjuryAug 16, 2026Failure to Advance

  It was reported that during an upgrade procedure, the physician was unable to remove the stylet from the left ventricular (LV) lead while attempting to implant it. The lead was removed and replaced with another lead. During placement of the replacement LV lead, the physician was unable to advance the lead. An echocardiogram and contrast were performed, and cardiac perforation and pericardial effusion were identified and associated with both leads. Both leads were removed, and a port plug was placed in the LV port of the device. The patient was discharged following the surgery.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50267062 ↗
• InjuryAug 16, 2026Separation Problem

  It was reported that during an upgrade procedure, the physician was unable to remove the stylet from the left ventricular (LV) lead while attempting to implant it. The lead was removed and replaced with another lead. During placement of the replacement LV lead, the physician was unable to advance the lead. An echocardiogram and contrast were performed, and cardiac perforation and pericardial effusion were identified and associated with both leads. Both leads were removed, and a port plug was placed in the LV port of the device. The patient was discharged following the surgery.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50263550 ↗
• MalfunctionAug 11, 2026High impedance

  It was reported that the patient was remotely monitored through a Merlin.net transmission. The transmission indicated high pacing impedance measurements on the left ventricular (LV) lead. No intervention or patient condition was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50205409 ↗
• MalfunctionAug 11, 2026Failure to Capture; High impedance

  It was reported that the patient presented to the hospital for an implant procedure. During the procedure, it was noted that the left ventricular (LV) lead exhibited a high capture threshold resulting in loss of capture. Multiple attempts at different locations were made, but the issue persisted and high pacing impedance was noted. The LV lead was not used and was replaced with a left bundle branch (LBB) lead on (b)(6) 2026. The patient was discharged post-procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204708 ↗
• InjuryAug 7, 2026Failure to Capture; Migration or Expulsion of Device

  It was reported that the patient presented to the emergency room experiencing worsened shortness of breath. Device interrogation revealed that the left ventricular (LV) lead failed to capture at high output. Fluoroscopy performed during the lead repositioning procedure confirmed that the LV lead had migrated into the right atrium, due to poor patient anatomy. The LV lead was explanted and replaced. There were no patient consequences.

  Patient problems: Dyspnea

  MAUDE report 50171686 ↗
• MalfunctionAug 6, 2026Break; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159964 ↗
• MalfunctionAug 6, 2026Use of Device Problem; Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50152024 ↗
• InjuryJul 6, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) OVERSENSING WAS SEEN OVER REMOTE TRANSMISSION. IT WAS DISCOVERED TO ACTUALLY BE CAUSED BY RIGHT VENTRICULAR (RV) LEAD NOISE AND THIS RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). PROGRAMMING CHANGES WERE MADE AND HIGH VOLTAGE THERAPIES WERE DISABLED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25718937 ↗
• InjuryJun 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A LEAD EXPLANT PROCEDURE. DEVICE INTERROGATION PRIOR TO THE PROCEDURE INDICATED THAT THE LEFT VENTRICULAR (LV) WAS PROGRAMMED OFF; FLUOROSCOPY WAS PERFORMED AND CONFIRMED THAT THE LV LEAD HAD PULLED BACK. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25603329 ↗
• MalfunctionJun 23, 2026Low impedance

  IT WAS REPORTED THAT PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, THE LEFT VENTRICLE LEAD EXHIBITED LOW PACING IMPEDANCE. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25589928 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND LEFT VENTRICULAR (LV) LEADS. THE ICD, RA, RV, AND LV LEADS WERE ALL EXPLANTED AND REPLACED. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25486888 ↗
• InjuryMay 29, 2026Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED FAILURE TO CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25338898 ↗
• InjuryMay 25, 2026Failure to Capture; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS RESULTING IN LOSS OF CAPTURE. FURTHER INVESTIGATIONS REVEALED THAT THE LV LEAD HAD MIGRATED OUT OF THE CORONARY SINUS (CS) BRANCH IN WHICH IT WAS INITIALLY PLACED. THE LV LEAD WAS EXPLANTED AND REPLACED WITH A LEFT BUNDLE BRANCH PACING (LBBP) LEAD AS THE VESSEL WAS NOT ACCESSIBLE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273300 ↗
• InjuryMay 21, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. IT WAS NOTED THAT FAILURE TO CAPTURE AND HIGH CAPTURE THRESHOLDS WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) AND THE LEFT VENTRICULAR (LV) LEADS. DISLODGEMENT WAS CONFIRMED VIA IMAGING ON THE LV LEAD. THE RV AND LV LEADS WERE EXPLANTED AND REPLACED SUCCESSFULLY. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249834 ↗
• InjuryMay 18, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED, A LOSS OF CAPTURE WAS OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD. DIAGNOSTIC IMAGING WAS PERFORMED AND THE LV LEAD HAD DISLODGED, WHICH WAS SUSPECTED TO BE DUE TO PATIENT AMBULATION. THE LV LEAD WAS EXPLANTED AND REPLACED. ADDITIONALLY, THE DEVICE WAS ALSO REPLACED DUE TO POCKET EROSION WHICH WAS SUSPECTED TO BE DUE TO POCKET CLOSURE. NO INFECTION WAS OBSERVED. THE PATIENT WAS STABLE AND WILL CONTINUE BEING MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209735 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT IN THE CLINIC WITH INFECTION AND POCKET EROSION. IT WAS NOTED THAT FLUID HAD LEAKED FROM THE DEVICE POCKET, AND THE DEVICE WAS VISIBLE THROUGH THE OPENED INCISION SITE OF THE IMPLANTED DEVICE POCKET. THE INFECTION WAS RELATED TO THE SYSTEM IMPLANT PROCEDURE. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM, INCLUDING THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD), THE RIGHT ATRIAL LEAD, THE RIGHT VENTRICULAR LEAD, AND THE LEFT VENTRICULAR LEAD. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 25134022 ↗