Quartet™ 1458Q-86Recalls & reported problems
St. Jude Medical, Inc. · Left Heart Lead · Class 3 · Implant
All models of Quartet (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Quartet left heart lead is a wire placed on the left side of the heart as part of a defibrillator system. Of its 6,629 reports, 208 describe deaths and 3,591 describe injuries. Many describe the lead moving out of place or failing to make the heart respond, along with high electrical resistance and breaks. Recent reports describe leads being capped and replaced during procedures. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 6,631
- Deaths reported
- 207
- Injuries reported
- 3,597
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6,631 adverse event reports that list this exact device (DI 05414734503198), received between Jun 11, 2018 and Sep 30, 2026 — classified as 207 deaths, 3,597 injuries, 2,827 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2,103 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2,103
- Failure to Capture1,847
- Adverse Event Without Identified Device or Use Problem1,280
- High impedance619
- Capturing Problem610
- Break430
- Failure to Advance384
- High Capture Threshold334
Patient problems
- No Clinical Signs, Symptoms or Conditions3,127
- No Known Impact Or Consequence To Patient1,428
- Unspecified Infection920
- Discomfort343
- No Consequences Or Impact To Patient210
- Death142
- Undesired Nerve Stimulation105
- Dyspnea78
Recent adverse event reports
The 25 most recent of 6,631 reports, in the reporter's own words as published by the FDA.
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, 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, 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 ↗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 ↗MalfunctionSep 24, 2026Low impedance
During remote follow-up, low pacing impedance was observed on the left ventricular (LV) lead. No intervention has been performed at this time. The patient was stable and will continue to be monitored.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884249 ↗MalfunctionSep 24, 2026Device Dislodged or Dislocated
It was reported that the patient presented for an implant procedure. During the procedure, the left ventricular (LV) lead became dislodged following sheath removal. As a result, the LV lead was not implanted and was replaced during the same procedure. The patient remained stable throughout the procedure, and no adverse patient consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50879103 ↗MalfunctionSep 24, 2026Break
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 was found to be damaged when repositioned. The LV lead was not used and was replaced on (b)(6) 2026. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876993 ↗MalfunctionSep 23, 2026Break
It was reported that the patient presented to the hospital for an implant procedure. During the procedure, the physician suspected that the left ventricular (LV) lead may have been damaged. The LV lead was not used and was replaced on (b)(6) 2026. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864372 ↗InjurySep 23, 2026Failure to Capture; Over-Sensing; Device Dislodged or Dislocated
It was reported that the patient presented for a clinical follow-up and experienced dizziness, which was attributed to left ventricular (LV) lead noise reversion episodes. Upon evaluation, it was noted that the LV lead exhibited failure to capture. The healthcare professional speculated that the noise resulted in pacing inhibition. Fluoroscopy revealed that the LV lead had dislodged. The LV lead was explanted and replaced. The patient was discharged following the procedure.
Patient problems: Dizziness
MAUDE report 50863411 ↗InjurySep 18, 2026Failure to Capture; Device Dislodged or Dislocated
It was reported that the patient presented for a follow-up in clinic. Upon interrogation, it was noted that the left ventricular (LV) lead failed to capture. Chest X-ray revealed that the LV lead had dislodged. The LV lead was capped and replaced on (b)(6) 2026. The patient remained in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50814046 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient presented with an infection and discomfort noted on the patient's implantable cardioverter defibrillator system. The system was explanted and replaced on (b)(6)2026. No adverse patient consequences were reported.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 50813751 ↗InjurySep 18, 2026High impedance; Therapy Delivered to Incorrect Body Area; Material Twisted/Bent
It was reported that the patient was experiencing Phrenic Nerve Stimulation (PNS) due to the left ventricular (LV) lead. Additionally, increased pacing impedance was observed on the LV lead. The lead was explanted and replaced. Visually twisting of the lead body was observed. The patient was in stable condition.
Patient problems: Discomfort
MAUDE report 50813201 ↗MalfunctionSep 17, 2026Break; Fracture
It was reported that during an attempted implant, frayed insulation and a fracture were visually observed on the left ventricular (LV) lead. The LV lead was replaced. The patient was in stable condition with no adverse events.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804032 ↗InjurySep 16, 2026Failure to Capture; Fracture; High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794743 ↗MalfunctionSep 14, 2026Failure to Capture; High impedance
It was reported that the patient presented for an implant procedure. During the procedure, the left ventricular (LV) lead exhibited high pacing impedance and a high capture threshold, resulting in loss of capture. The LV lead was not implanted, and the procedure was abandoned. The patient remained in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749859 ↗MalfunctionSep 14, 2026Over-Sensing
It was reported that the patient presented remotely via Merlin.net. It was noted that the left ventricular lead exhibited noise over-sensing resulted in noise reversion episodes. No intervention was performed. The were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749696 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented to the hospital with sepsis, fever and redness and swelling at the device implant site due to infection. It was also noted that the patient's left ventricular (LV) lead had vegetation due to the infection which was noted via echocardiography. The physician stated that the infection was not related to Abbotts' devices. The patient's implantable cardioverter defibrillator, the LV lead, the right atrial lead and the right ventricular lead were explanted due to the infection. A new system was implanted. The patient was stable throughout.
Patient problems: Fever; Unspecified Infection
MAUDE report 50749361 ↗MalfunctionSep 13, 2026Intermittent Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747239 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 reports
- Claria MRI™ Quad CRT-D SureScan™ DTMA1QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)22 deaths1,479 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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