QuartetRecalls & reported problems across all models

We found 10 models of Quartet by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 11,001 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2018 and Sep 30, 2026 — classified as 322 deaths, 6,171 injuries, 4,508 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3,777 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Quartet problems

Quartet models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Quartet™ 1458Q-86

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  207 deaths6,631 reports
• Quartet™ 1456Q/86

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  25 deaths1,372 reports
• Quartet™ 1457Q-86

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  21 deaths1,061 reports
• Quartet™ 1458QL/86

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  25 deaths896 reports
• Quartet™ 1458Q-75

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  23 deaths545 reports
• Quartet™ 1458Q

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  15 deaths314 reports
• Quartet™ 1457Q

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  5 deaths86 reports
• Quartet™ 1456Q

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death49 reports
• Quartet™ 1458QL

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  44 reports
• Quartet™ 1458QL

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 reports

Recent Quartet adverse event reports

The 15 most recent reports across all models, 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 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had bacteremia and their Implantable Cardioverter Defibrillator (ICD), right ventricular (RV) lead, right atrial (RA) lead, and left ventricular (LV) lead were explanted as a result. The patient was stable.

  Patient problems: Unspecified Infection

  MAUDE report 50951664 ↗
• MalfunctionSep 29, 2026High impedance; Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941363 ↗
• MalfunctionSep 29, 2026Failure to Capture; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937473 ↗
• InjurySep 29, 2026Failure to Capture; Separation Failure; Device Dislodged or Dislocated

  It was reported that loss of capture was noted on the left ventricle (LV) lead. The device was reprogrammed to deactivate the LV lead. Later, lead migration occurred during a revision procedure. Repositioning using a guidewire was attempted, however, the guidewire was unable to release from the LV lead. The LV lead was explanted and replaced. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936437 ↗
• InjurySep 29, 2026Capturing Problem

  It was reported that the patient presented in clinic for routine follow-up. An interrogation found that their Right Ventricular (RV) and Left Ventricular (LV) leads exhibited high capture thresholds. During revision procedure, it was noted that the RV lead helix failed to retract and ended up becoming stretched. The RV lead was explanted and replaced. While attempting to implant the replacement LV lead, it was noted that the patient had stenosis, resulting in the replacement lead failing to advance. The attempted replacement LV lead was not implanted, and another lead was implanted successfully on (b)(6) 2026. The patient was stable throughout.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936433 ↗
• 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 ↗
• InjurySep 29, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927576 ↗
• MalfunctionSep 29, 2026Break

  It was reported that the patient presented for an implant procedure. During the procedure, it was noted that the left ventricular (LV) lead was damaged while being advanced through a tortuous coronary sinus (CS). 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 50927266 ↗
• 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 ↗
• MalfunctionSep 25, 2026Failure to Capture

  It was reported that during an implant surgery, the left ventricular lead positioned in the posterior vein exhibited loss of capture. The lead was not used, and a new one was successfully implanted. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899168 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with an infection at the device site. The cause of the infection was unclear. There was no erosion of the device and leads and no vegetation was found on the leads. 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 50894242 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for a clinical follow up. It was noted that the patient had experienced persistent redness and swelling at the cervical pocket site, along with symptoms of a pocket infection, for the past six months. The entire system, including the Implantable Cardioverter Defibrillator (ICD), right ventricular lead, right atrial lead, and left ventricular lead, was explanted. The patient remained in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50893652 ↗
• InjurySep 25, 2026Capturing Problem

  Patient problems: Discomfort

  MAUDE report 50892649 ↗
• InjurySep 24, 2026Failure to Capture; Failure to Disconnect; Device Dislodged or Dislocated

  It was reported that the patient presented to a routine generator change. Prior to the procedure, the Left Ventricular lead exhibited loss of capture as it had dislodged. While attempting to extract the lead, the distal portion of the lead was stuck due to calcium build up. The doctor decided to cap the lead, and a new one was implanted on (b)(6) 2026. There was no patient consequences reported. Patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886305 ↗

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