Quartet™ 1456Q/86Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,372 adverse event reports that list this exact device (DI 05414734510158), received between Jun 12, 2018 and Sep 23, 2026 — classified as 25 deaths, 707 injuries, 640 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (497 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 1,372 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with a pocket infection. The physician explanted the implantable cardioverter defibrillator, right ventricular lead, right atrial lead, and left ventricular lead. The patient remained in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50863286 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50831574 ↗
• InjurySep 18, 2026Device Dislodged or Dislocated

  During an in-clinic follow-up, diagnostic imaging was performed and revealed a dislodgement on the left ventricular (LV) lead. The lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820638 ↗
• MalfunctionSep 14, 2026Use of Device Problem; Insufficient Device Problem Information

  It was reported that the patient presented for an implanted procedure. During the procedure, while attempting to implant the lead, the lead could not be implanted in the desired position and exhibited unsatisfactory parameters. The lead was not used and the patient experienced no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753224 ↗
• InjurySep 9, 2026Therapy Delivered to Incorrect Body Area

  It was reported that the patient experienced diaphragmatic muscle stimulation from the left ventricular (LV) lead. The LV lead was explanted and replaced to resolve this event. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689967 ↗
• InjurySep 9, 2026Therapy Delivered to Incorrect Body Area

  It was reported that the patient with discomfort presented for a follow-up in clinic. Upon interrogation, it was noted that the left ventricular (LV) lead exhibited diaphragmatic stimulation in every vector. The LV lead was explanted and replaced with an LV epicardial lead. The patient was in stable condition.

  Patient problems: Discomfort

  MAUDE report 50683949 ↗
• MalfunctionSep 8, 2026Failure to Capture

  It was reported that the patient presented for an implant procedure. During the procedure, after the left ventricular (LV) lead was positioned in the posterior left ventricular (PLV) vein, it was noted that the LV lead exhibited loss of capture on all vectors. The LV lead was not used and replaced. The patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50659866 ↗
• MalfunctionSep 4, 2026Failure to Capture

  It was reported that the patient presented to hospital for an implant procedure. During the procedure, it was noted that the left ventricular (LV) lead exhibited failure to capture despite multiple repositioning attempts. The LV lead was not used and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50604495 ↗
• InjurySep 1, 2026Capturing Problem

  It was reported that the patient presented in the hospital for lead revision. The patient's left ventricular (LV) lead exhibited high capture threshold. The LV lead was capped and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50536817 ↗
• MalfunctionSep 1, 2026Failure to Capture

  It was reported that the patient presented for an implant procedure. During the procedure, it was noted that the left ventricular (LV) lead exhibited loss of capture. The LV lead was not used and replaced. The patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50535716 ↗
• MalfunctionAug 21, 2026Separation Failure; Detachment of Device or Device Component

  During initial implant, the stylet was unable to be separated from the left ventricular (LV) lead. After multiple attempts to remove the stylet, the connector pin detached. The LV lead was explanted and replaced to resolve event. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50370179 ↗
• MalfunctionAug 20, 2026Break; Separation Failure

  It was reported that during an implant procedure, the left ventricle (LV) lead was positioned using an introducer. During the slitting process, the slitter became lodged partway through and could neither be advanced nor withdrawn. As a result, all components had to be removed. Due to concerns that the LV lead may have been damaged during the event, the LV lead was replaced with a new lead. The procedure was then successfully completed. The patient had no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50337230 ↗
• MalfunctionAug 19, 2026High impedance

  It was reported through a remote transmission that noise over-sensing and high capture threshold were noted on the patient's pacemaker and the right atrial (RA) lead. Meanwhile, high pacing impedance measurements were noted on the patient's pacemaker, the left ventricular (LV) and the right ventricular (RV) leads from the same remote transmission. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50314711 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the emergency room with a scab and yellow discharge draining from the device pocket. The patient was noted to have a pocket infection with dehiscence, through which a suture sleeve was visible. An echocardiogram was performed. The physician explanted the entire system, including the implantable cardioverter-defibrillator (ICD), right atrial (RA) lead, right ventricular (RV) lead, and left ventricular (LV) lead. A new implantable cardioverter-defibrillator (ICD), along with RA, RV lead and LV lead, was implanted on (b)(6) 2026. The patient remained in stable condition.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 50271597 ↗
• InjuryAug 14, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient's left ventricular (LV) lead exhibited high capture threshold and loss of capture. Imaging was performed and confirmed that LV lead pulled back out of the coronary sinus (CS). The physician elected to explant the lead. The patient condition remained stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261380 ↗
• MalfunctionAug 13, 2026Failure to Capture; Low impedance

  It was reported that the patient presented to the hospital for a scheduled implant procedure. During the procedure, the left ventricular (LV) lead exhibited low pacing impedance and loss of capture. The LV lead was removed and replaced. The patient was discharged with no reports of adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231116 ↗
• MalfunctionAug 12, 2026Separation Failure

  It was reported that the patient presented for an implant procedure. During the procedure, the first left ventricular (LV) lead was implanted with acceptable electrical parameters. However, when the physician attempted to remove the guidewire, it became stuck within the lead. As a result, the physician elected to remove the first LV lead, and a second LV lead was introduced. Following implantation of the second LV lead, high pacing impedance was observed despite multiple repositioning attempts. Both LV leads were not used and replaced with a third LV lead, which was implanted in a different vein with satisfactory electrical parameters. The patient remained in a stable condition throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218447 ↗
• InjuryAug 10, 2026Therapy Delivered to Incorrect Body Area

  It was reported that the patient presented for a clinical follow-up with discomfort due to extracardiac stimulation from the left ventricular (LV) lead. The device had been programmed to right ventricular (RV)-only pacing. The patient's anatomy was not compatible with alternative coronary sinus (CS) lead placement. Consequently, the LV lead was explanted and replaced with an epicardial lead. The patient remained in stable condition throughout the event.

  Patient problems: Discomfort

  MAUDE report 50189708 ↗
• MalfunctionAug 10, 2026Break; Use of Device Problem

  It was reported that the patient presented for an implant procedure. During the procedure, it was noted that the lead was stuck on tissue and got damaged. The lead was not used, and a new lead was implanted. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189487 ↗
• MalfunctionJul 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50107458 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during an implant procedure, the left ventricular (LV) lead perforated the heart and caused venous dissection, resulting in pericardial effusion and cardiac tamponade. As a result, pericardial drainage was performed, and the physician elected not to proceed with the implant procedure. The patient's condition remained stable.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion; Vascular Dissection

  MAUDE report 50107336 ↗
• MalfunctionJun 23, 2026Use of Device Problem

  IT WAS REPORTED DURING IMPLANT PROCEDURE THAT THE LEFT VENTRICULAR LEAD COULD NOT BE FIXATED. DURING THE OPERATION, THE PATIENT SUFFERED HEART FAILURE SYMPTOMS AND THE PROCEDURE WAS RESCHEDULED FOR A LATER DATE. THERE WAS NO ALLEGATION THAT THE HEART FAILURE WAS CAUSED BY THE LEAD. THE PATIENT WAS STABLE FOLLOWING PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25602838 ↗
• InjuryJun 15, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP VISIT IN THE CLINIC AND HAD EXPERIENCED MULTIPLE FALLS POST-IMPLANT DUE TO IMBALANCE AND GAIT DISTURBANCE. DEVICE INTERROGATION SHOWED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED FAILURE TO CAPTURE. FLUOROSCOPY CONFIRMED LV LEAD DISLODGEMENT. THE LV LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND THE PATIENT WAS DISCHARGED FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513665 ↗
• MalfunctionJun 9, 2026Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT PROCEDURE. DURING THE PROCEDURE, THE LOW VOLTAGE LEAD WAS NOTED TO HAVE A FAULTY PROBE. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD WAS REPORTED TO BE CONTAMINATED. THE LEFT BUNDLE BRANCH PACING (LBBP) LEAD IMPLANTATION WAS ALSO CANCELLED FOR UNKNOWN REASONS. ALL THREE LEADS WERE NOT USED AND WERE SUBSEQUENTLY REPLACED. THE PATIENT¿S CONDITION WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25452119 ↗
• InjuryJun 4, 2026Capturing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD AN EXTREME CASE OF TWIDDLER'S BUT EXPERIENCED NO SYMPTOMS. ALL THE LEADS WERE PULLED BACK. THE CAPTURE THRESHOLDS WERE ELEVATED ON THE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS. THE SENSING HAD DROPPED AND PACING IMPEDANCE WAS HIGH ON BOTH THE RV AND RA LEADS. THE SYSTEM WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399844 ↗