Quartet™ 1458Q-75Recalls & reported problems

Summary

The FDA's MAUDE database contains 545 adverse event reports that list this exact device (DI 05414734503334), received between Jun 20, 2018 and Sep 23, 2026 — classified as 23 deaths, 375 injuries, 147 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (170 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 545 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 infection and endocarditis at device pocket. The infection was not associated with any Abbott product and/or procedure. The endocarditis was confirmed via diagnostic imaging. The whole system was explanted and replaced. The patient was in stable condition throughout the procedure.

  Patient problems: Unspecified Infection

  MAUDE report 50864485 ↗
• MalfunctionSep 17, 2026Separation Failure

  It was reported that during the implantation procedure, a left ventricular lead was positioned in the target coronary sinus vein. When the physician attempted to retract the stylet, it was found to be stuck within the lead body. Multiple attempts to remove the stylet resulted in damage to the lead connector and internal components. The lead was successfully explanted and replaced. Patient was discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805247 ↗
• InjurySep 8, 2026Capturing Problem

  It was reported that the patient presented to the clinic for a scheduled follow-up visit. Interrogation revealed that the left ventricular (LV) lead demonstrated high capture threshold measurements. 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 50660300 ↗
• InjuryAug 25, 2026Fracture; High impedance

  It was reported that Left Ventricular (LV) lead was explanted due to high impedance. Lead fracture near the header was noted when the pocket was opened. The patient is in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50431356 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with a large, oozing scab at the device implantation site secondary to an infection. The physician elected to explant the entire pacing system, including the pacemaker, right ventricular (RV), the right atrial (RA), and left ventricular (LV) leads, on (b)(6)2026. The patient was in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50205319 ↗
• InjuryAug 4, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient's left ventricular (LV) lead exhibited chronic loss of capture. Further examination revealed that the LV lead had dislodged back into the inferior vena cava (IVC). The LV lead was then capped on (b)(6) 2026. No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125464 ↗
• MalfunctionJun 24, 2026Break; Separation Failure

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE STYLET COULD NOT BE REMOVED FROM THE LEAD VENTRICULAR LEAD, AND THE LEAD WAS DAMAGED DURING THE ATTEMPT. THE LEAD WAS REMOVED, AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. WITHOUT ISSUE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25613014 ↗
• InjuryMay 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THE LEFT VENTRICLE LEAD HAD BEEN DISLODGED. THE DISLODGEMENT WAS CONFIRMED BY DIAGNOSTIC IMAGING. THE LEAD WAS TURNED OFF AND SUBSEQUENTLY EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273371 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  NEW INFORMATION INDICATES THAT THE PATIENT PRESENTED WITH REDNESS AND DISCHARGE FROM THE PACEMAKER POCKET. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 25238353 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SUPERIOR VENA CAVA (SVC) SYNDROME. THE PHYSICIAN ELECTED TO EXPLANT THE RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND LEFT VENTRICULAR (LV) LEADS. THE PATIENT CONDITION WAS STABLE.

  Patient problems: Embolism/Embolus

  MAUDE report 25222072 ↗
• InjuryApr 30, 2026Therapy Delivered to Incorrect Body Area; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT DUE TO EXTRA-CARDIAC SIMULATION CAUSED BY THE LEFT VENTRICULAR (LV) LEAD. ADDITIONALLY, THE LV LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. ON (B)(6) 2026, THE PHYSICIAN CAPPED THE LV LEAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Discomfort

  MAUDE report 25052520 ↗
• InjuryApr 7, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. INTERROGATION REVEALED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED FAILURE TO CAPTURE IN ALL VECTORS AT MAXIMUM OUTPUT. CHEST X-RAY AND FLUOROSCOPY CONFIRMED THAT THE LV LEAD HAD DISLODGED, IT WAS PULLED BACK INTO THE CORONARY SINUS (CS). THE DEVICE WAS THEREFORE PROGRAMMED TO RIGHT VENTRICULAR (RV) ONLY PACING, THE LV LEAD WAS EVENTUALLY EXPLANTED AND REPLACED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811461 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH ENDOCARDITIS. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM, INCLUDING THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD), THE RIGHT VENTRICULAR LEAD, AND THE RIGHT ATRIAL LEAD. THE SYSTEM WAS REPLACED WITH A LEADLESS PACEMAKER. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 24754594 ↗
• MalfunctionMar 11, 2026Low impedance; Capturing Problem

  NEW INFORMATION RECEIVED NOTES THAT THE PACING IMPEDANCE OF THE LEFT VENTRICULAR (LV) LEAD HAD FURTHER DECREASED. NO INTERVENTIONS OR CHANGES WERE PERFORMED; THE LV LEAD WILL CONTINUE TO BE MONITORED. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566182 ↗
• MalfunctionMar 10, 2026Over-Sensing

  IT WAS REPORTED THAT NOISE RESULTING IN OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. RV LEAD DAMAGE WAS SUSPECTED BUT NOT CONFIRMED. THE DEVICE WAS REPROGRAMMED TO AND LEFT VENTRICULAR (LV) LEAD SENSING, HOWEVER, NOISE RESULTING IN OVERSENSING WAS OBSERVED ON THE LV LEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560329 ↗
• InjuryMar 5, 2026Fracture; Capturing Problem

  VOLUNTARY MEDWATCH RECEIVED STATES THAT LEFT VENTRICULAR (LV) LEAD FRACTURE WAS NOTED. THE PATIENT EXPERIENCED BIGEMINY AND THE LV LEAD EXHIBITED A CAPTURE ISSUE. THE PHYSICIAN EXPLANTED THE LV LEAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 24520922 ↗
• MalfunctionMar 3, 2026Break; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. NO INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN. NEW INFORMATION RECEIVED NOTES THAT THE HIGH DEFIBRILLATION IMPEDANCE WAS NOTED IN CLINIC. IMAGING WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION. NEW INFORMATION RECEIVED NOTES THAT THE PATIENT PRESENTED FOR AN EXPLANT PROCEDURE. DURING THE PROCEDURE, WHILE ATTEMPTING TO EXPLANT THE RIGHT VENTRICULAR (RV) LEAD, IT WAS NOTED THAT THE RV LEAD BROKE. UPON REVIEW, IT WAS NOTED THAT THE LV LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND FAILURE TO CAPTURE. IT WAS THEN NOTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS HARMED IN THE PROCESS OF EXTRACTING THE RV LEAD. THE LV LEAD WAS ATTEMPTED TO BE EXTRACTED AND BROKE. THE RV AND LV LEADS WERE CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501127 ↗
• InjuryMar 2, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. A DEVICE INTERROGATION WAS PERFORMED AND REVEALED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED FAILURE TO CAPTURE. A CHEST X-RAY WAS PERFORMED AND REVEALED THE LV LEAD WAS DISLODGED. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24487808 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH INFECTION AND SKIN EROSION AT DEVICE POCKET. THE GALLANT, RIGHT ATRIAL LEAD, RIGHT VENTRICULAR LEAD AND LEFT VENTRICULAR LEAD WERE EXPLANTED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24438963 ↗
• InjuryFeb 5, 2026Failure to Capture; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED DURING AN IN-CLINIC DEVICE UPGRADE EVALUATION, THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION FROM ITS LEFT VENTRICULAR (LV) LEAD. LOSS OF CAPTURE WAS ALSO NOTED. DURING THE DEVICE UPGRADE, THE LV LEAD WAS EASILY EXPLANTED, AND A NEW LV LEAD WAS IMPLANTED. THE PATIENT REMAINED STABLE AND WAS DISCHARGED SAME DAY.

  Patient problems: Discomfort

  MAUDE report 24270346 ↗
• InjuryFeb 3, 2026Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT THE PATIENT HAD PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LAB FOR PROCEDURE. THE PATIENT HAD EXPERIENCED PHRENIC NERVE STIMULATION, WHICH WAS ATTRIBUTED TO THE LEFT VENTRICULAR (LV) LEAD. PROGRAMMING CHANGES WERE PERFORMED ON OTHER VECTORS OF THE LV LEAD; HOWEVER, THE ISSUE PERSISTED. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Discomfort

  MAUDE report 24255001 ↗
• InjuryJan 30, 2026Failure to Capture; High impedance

  IT WAS REPORTED THAT NO CAPTURE AND HIGH PACING IMPEDANCE WERE NOTED ON A PATIENT'S LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS CAPPED ON (B)(6) 2026 AND A NEW LEAD WAS IMPLANTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24224897 ↗
• InjuryJan 22, 2026Fracture; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS. UPON REVIEW, IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A FRACTURE. WHILE ATTEMPTING TO EXPLANT THE LV LEAD, IT WAS NOTED THAT THE LEAD WAS TETHERED TO THE SITE OF INSERTION. THE LV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Dizziness

  MAUDE report 24148332 ↗
• MalfunctionDec 15, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED IMPLANT PROCEDURE. DURING THE PROCEDURE, THE QUADRIPOLAR LEFT VENTRICULAR (LV) LEAD FAILED TO ADVANCE THROUGH THE SUB-SELECTOR CATHETER. THE LV LEAD WAS REMOVED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812836 ↗
• MalfunctionNov 15, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IMPLANT OF THE LEFT VENTRICULAR LEAD. DURING THE PROCEDURE THE STYLET BECAME STUCK INSIDE THE LEAD. THE STYLET COULD NOT BE SEPARATED FROM THE LEAD; THEREFORE, IT WAS NOT IMPLANTED. A REPLACEMENT LEAD WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23563528 ↗