Quartet™ 1458QL/86Recalls & reported problems

Summary

The FDA's MAUDE database contains 896 adverse event reports that list this exact device (DI 05414734510219), received between Jun 12, 2018 and Sep 30, 2026 — classified as 25 deaths, 497 injuries, 374 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (286 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 896 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952247 ↗
• InjurySep 29, 2026Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated

  It was reported that during an implant procedure, the patient had only one suitable coronary sinus (CS) branch available for left ventricle (LV) lead placement. After initial placement, the only pacing vector that did not produce phrenic nerve stimulation (PNS) was D1-M3. However, the physician noted that D1-M3 was not available as a programmable pacing vector on the PM3562 device. During pocket closure, the LV lead dislodged as observed under fluoroscopy and required repositioning. Following repositioning, the D1-P4 vector achieved capture without PNS, allowing successful completion of the procedure. The patient was stable.

  Patient problems: Discomfort

  MAUDE report 50928102 ↗
• MalfunctionSep 17, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808373 ↗
• InjurySep 14, 2026Device Dislodged or Dislocated

  It was reported that the patient¿s left ventricular (LV) lead had dislodged. The LV lead was explanted and replaced. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50749559 ↗
• MalfunctionSep 13, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747947 ↗
• InjurySep 2, 2026Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50576649 ↗
• MalfunctionAug 31, 2026Break; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519748 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient presented with left subclavian stenosis resulting in blood clots and swelling to the left extremity. The physician elected to perform a laser lead extraction and place a right ventricle leadless pacemaker and a single chamber Implantable Cardioverter Defibrillator on the right side. The patient was stable following the procedure.

  Patient problems: Thrombosis/Thrombus; Valvular Stenosis

  MAUDE report 50500966 ↗
• MalfunctionAug 27, 2026High impedance; Capturing Problem

  It was reported that the patient presented remotely via Merlin.net. Upon review of the transmission, the left ventricular (LV) lead exhibited high pacing impedance and capture issues. No intervention was performed. No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50487950 ↗
• MalfunctionAug 19, 2026Use of Device Problem; Detachment of Device or Device Component

  It was reported that the patient presented for an implant procedure. During the procedure, after the left ventricular (LV) lead was implanted and during attempt to secure the lead with suture sleeve, the suture sleeve could not be secured and the lead slid through the suture sleeve. A new suture sleeve was used, and the lead was secured successfully. The patient was stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50316514 ↗
• InjuryAug 19, 2026Failure to Capture; Use of Device Problem; Device Dislodged or Dislocated

  The patient presented to the clinic for a scheduled follow-up visit. Interrogation revealed loss of sensing and loss of capture of the right atrial (RA) lead, as well as loss of capture of the left ventricular (LV) lead. A chest X-ray confirmed dislodgement of both the RA and LV leads. A planned dual-lead revision procedure was scheduled via a right-sided approach due to left subclavian vein occlusion. During the procedure, the LV lead could not be explanted because of extensive fibrotic tissue encasing the lead body. Consequently, the physician elected to explant the RA lead and reposition the chronic LV lead into the right atrium to provide atrial sensing and trigger right ventricular pacing. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50316272 ↗
• InjuryAug 17, 2026High impedance

  It was reported that the patient presented to hospital for a follow up. It was noted that the left ventricular (LV) lead exhibited high out of range pacing impedance. The LV lead was capped and replaced on (b)(6) 2026. The patient was discharged post procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50270174 ↗
• MalfunctionAug 6, 2026High impedance; Low impedance; Capturing Problem

  It was reported that high capture threshold and decreased pacing impedance were observed on the right ventricular (RV) lead and the left ventricular (LV) lead. Decreased defibrillation impedance was observed on the RV lead. No intervention was performed. The patient was stable and will continue to be monitored. There were no adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161875 ↗
• InjuryAug 6, 2026High impedance; Device Dislodged or Dislocated

  It was reported that the patient's left ventricular (LV) lead exhibited high impedance. Fluoroscopy performed confirmed that the lead had dislodged and coiled up due to patient's Twiddler's syndrome. The lead was explanted, however, due to difficult patient's anatomy, a new LV lead implant attempt was unsuccessful. Therefore, the LV port was plugged and the device was reprogrammed. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50151798 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A POCKET INFECTION. THE ENTIRE SYSTEM, INCLUDING THE PACEMAKER, RIGHT VENTRICULAR LEAD, RIGHT ATRIAL LEAD, AND LEFT VENTRICULAR LEAD, WAS EXPLANTED AND REPLACED WITH A TEMPORARY LEAD ON (B)(6) 2026. THE TEMPORARY LEAD WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A NEW PACEMAKER SYSTEM ON (B)(6) 2026. PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 25686969 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH A SYSTEMIC INFECTION. ADDITIONALLY, VEGETATION WAS OBSERVED ON THE PATIENT'S VALVE AND LEADS. THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) AND THE RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND LEFT VENTRICULAR (LV) LEADS WERE EXPLANTED. THE ICD SYSTEM WAS REPLACED ON (B)(6) 2026. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 25685940 ↗
• InjuryJun 25, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. INTERROGATION DURING THE PROCEDURE REVEALED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED FAILURE TO CAPTURE. THE LV LEAD WAS LATER CONFIRMED TO HAVE DISLODGED VIA CHEST X-RAY. THE LV LEAD WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630763 ↗
• MalfunctionJun 23, 2026Capturing Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD. NO INTERVENTION WAS PERFORMED, AND THE PATIENT WILL CONTINUE TO BE MONITORED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25603263 ↗
• InjuryJun 17, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD HAD FAILED TO CAPTURE. FLUOROSCOPY PERFORMED CONFIRMED THAT THE LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25541796 ↗
• MalfunctionJun 17, 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 FAILURE TO CAPTURE. THE LV LEAD WAS NOT USED AND WAS REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25541673 ↗
• MalfunctionJun 16, 2026Failure to Capture; High impedance; Therapy Delivered to Incorrect Body Area; Difficult to Remove

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PATIENT¿S LEFT VENTRICULAR (LV) LEAD DEMONSTRATED FAILURE TO CAPTURE, HIGH PACING IMPEDANCE, AND DISCOMFORT DUE TO EXTRACARDIAC STIMULATION. DURING A REPOSITION ATTEMPT ON (B)(6) 2026, THE LV LEAD WAS FOUND TO BE DIFFICULT TO REMOVE DUE TO BEING STUCK IN THE PATIENT¿S VEIN. THE LV LEAD WAS SUBSEQUENTLY CAPPED ON (B)(6) 2026 AND SUCCESSFULLY REPLACED. THE PATIENT REMAINED STABLE.

  Patient problems: Discomfort

  MAUDE report 25527782 ↗
• MalfunctionJun 15, 2026Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE FAILED TO ADVANCE THROUGH THE LEFT VENTRICULAR LEAD. THE LEAD WAS NOT USED AND REPLACED DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498075 ↗
• InjuryJun 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED DURING AN IN-CLINIC FOLLOW-UP, DISLODGMENT OF THE LEFT VENTRICULAR (LV) LEAD WAS NOTED. X-RAY CONFIRMED THE LV LEAD HAD DISLODGED. THE PHYSICIAN ELECTED TO EXPLANT THE LV LEAD AND REPLACE IT WITH A NEW ONE. THE PATIENT¿S CONDITION REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25438760 ↗
• MalfunctionJun 8, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THE LEFT VENTRICULAR (LV) LEAD HAD DISLODGED AND EXHIBITED FAILURE TO CAPTURE. THE DISLODGEMENT OF THE LV LEAD WAS VERIFIED BY FLUOROSCOPY. THE LV LEAD IS NOT USED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25438457 ↗
• InjuryMay 10, 2026Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC WITH A COMPLAINT OF DISCOMFORT. EXAMINATION REVEALED THAT THE LEFT VENTRICULAR (LV) LEAD CAUSED PHRENIC NERVE STIMULATION WHICH COULD NOT BE ELIMINATED BY REPROGRAMMING. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT REMAINED STABLE BEFORE, DURING AND AFTER THE PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 25133638 ↗