Quartet™ 1458QRecalls & 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 1458Q is a heart lead, a wire that connects an implanted defibrillator to the heart. Many of the 315 reports describe the lead moving out of position or pulses failing to make the heart beat. There were 202 injury reports and 15 deaths, and no recalls name this device. Reports fell to 15 in the latest 12 months from 30 in the 12 months before.
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
- 314
- Deaths reported
- 15
- Injuries reported
- 200
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 314 adverse event reports that list this exact device (DI 05414734503358), received between Jun 10, 2018 and Sep 9, 2026 — classified as 15 deaths, 200 injuries, 99 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (100 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 Dislocated100
- Failure to Capture83
- Adverse Event Without Identified Device or Use Problem76
- Capturing Problem34
- High impedance21
- High Capture Threshold16
- Therapy Delivered to Incorrect Body Area16
- Break14
Patient problems
- No Clinical Signs, Symptoms or Conditions118
- No Known Impact Or Consequence To Patient80
- Unspecified Infection52
- Discomfort14
- No Consequences Or Impact To Patient10
- Death9
- Dyspnea8
- Muscle Stimulation6
Recent adverse event reports
The 25 most recent of 314 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented with a pocket infection. The device pocket was visibly swollen. It was believed that the pocket infection was procedure-related, as it occurred following a device upgrade procedure. To resolve the issue, the left ventricular (LV) lead was explanted. The device and the remaining leads remained implanted. The patient remained in stable condition.
Patient problems: Unspecified Infection
MAUDE report 50693988 ↗MalfunctionSep 8, 2026High impedance
Patient problems: Insufficient Information
MAUDE report 50675386 ↗MalfunctionJun 9, 2026High impedance; Capturing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION INDICATED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED GRADUALLY INCREASED PACING IMPEDANCE WHICH WAS GREATER THAN UPPER LIMIT ALERT. ADDITIONALLY, THE LV THRESHOLD TREND WAS INCREASED CONCURRENTLY WITH THE PACING IMPEDANCE. NO CHANGES OR INTERVENTION WERE REPORTED. THE PATIENT CONDITION WAS NOT KNOWN.
Patient problems: Insufficient Information
MAUDE report 25441295 ↗InjuryApr 13, 2026Capturing Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD MEASUREMENTS. THE LV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS DISCHARGED WITH NO REPORTS OF ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24858972 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL WITH INFECTION AND SKIN EROSION AT DEVICE POCKET. THE CAUSE OF THE INFECTION WAS NOT IDENTIFIED. ECHOCARDIOGRAPHY SHOWED NO EVIDENCE OF VEGETATION NOTED ON THE LEADS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), 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 24635666 ↗InjuryMar 18, 2026Failure to Capture
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW-UP DEVICE CHECK. IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630593 ↗InjuryMar 16, 2026Failure to Capture; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT PRESENTED FOR A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRTP) REPLACEMENT WITH LEFT VENTRICULAR (LV) LEAD REVISION AS THE EXISTING LV LEAD HAD PREVIOUSLY BEEN PROGRAMMED OFF. DURING THE PROCEDURE, THE LV LEAD DEMONSTRATED NO CAPTURE AT MAXIMUM OUTPUT AND WAS OBSERVED UNDER FLUOROSCOPY TO BE FULLY DISLODGED. THE PHYSICIAN ELECTED TO CAP THE LV LEAD, AND A NEW LEAD WAS IMPLANTED SUCCESSFULLY ON (B)(6) 2026. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24602767 ↗MalfunctionMar 4, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR THE RIGHT VENTRICULAR (RV) LEAD EXTRACTION PROCEDURE DUE TO SEVERE TRICUSPID REGURGITATION (TR). DURING THE PROCEDURE, THE RIGHT ATRIAL (RA) AND THE LEFT VENTRICULAR (LV) LEADS WERE DISLODGED. THE WHOLE SYSTEM WAS EXPLANTED, AND THE RV LEAD WAS REPLACED ON (B)(6) 2026. LATER, ON (B)(6) 2026 THE LV LEAD WAS REIMPLANTED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24510012 ↗DeathMar 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503372 ↗InjuryJan 15, 2026Failure to Capture; Therapy Delivered to Incorrect Body Area
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL. LOSS OF CAPTURE AND PHRENIC NERVE STIMULATION (PNS) WERE NOTED ON THE PATIENT¿S LEFT VENTRICULAR (LV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT THE LV LEAD AND UPGRADE FROM A BIVENTRICULAR PACEMAKER TO A LEFT BUNDLE BRANCH PACING SYSTEM WITH RV PACING. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: Discomfort
MAUDE report 24089307 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LEAD VEGETATION. THE PATIENT HAD DONE ANTI-FUNGAL TRANSFUSION. NO OTHER INFORMATION WAS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 24036884 ↗MalfunctionDec 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC AND IT WAS FOUND THAT ONE OF THEIR LOW VOLTAGE LEADS HAD DISLODGED. NO CHANGES OR INTERVENTIONS WERE REPORTED. THE PATIENT CONDITION WAS NOT KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687300 ↗InjuryNov 19, 2025Capturing Problem; Capturing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A SCHEDULED FOLLOW UP. UPON INTERROGATION, IT WAS FOUND THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD WAS PROGRAMMED OFF PRIOR TO 2018 DUE TO HIGH CAPTURE THRESHOLD MEASUREMENTS. THE PHYSICIAN ELECTED TO REPLACE THE LV LEAD ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23601191 ↗InjuryNov 14, 2025Capturing Problem; Capturing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN-CLINIC FOLLOW UP. AN ECHOCARDIOGRAM REVEALED THAT THE PATIENT EXPERIENCED WORSENING HEART FAILURE WITH REDUCED EJECTION FRACTION. A DEVICE INTERROGATION FOUND THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD. FLUOROSCOPY REVEALED THAT THE LEAD WAS IN THE OPTIMAL POSITION. HOWEVER, IT WAS DECIDED THAT THE PATIENT REQUIRED A DIFFERENT TREATMENT MODALITY. THE PATIENT WAS SCHEDULED FOR REVISION AND THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS DISCHARGED.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 23562181 ↗InjuryOct 30, 2025Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL FOR LEAD REVISION. THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE DUE TO THE LEAD DISLODGEMENT. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433331 ↗InjuryAug 28, 2025Failure to Capture; Failure to Capture
IT WAS REPORTED THAT PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT LEFT VENTRICLE (LV) LEAD EXHIBITED FAILURE TO CAPTURE. THE LV LEAD WAS CAPPED ON (B)(6) 2025 AND REPLACED WITH NEW LEAD. PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910766 ↗InjuryAug 26, 2025Failure to Capture; Failure to Capture
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A GENERATOR CHANGE PROCEDURE. PRIOR TO THE PROCEDURE, UPON INTERROGATION, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE. THE LV LEAD WAS CAPPED ON (B)(6) 2025. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22901301 ↗InjuryAug 18, 2025Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE. IT WAS NOTED THAT THE LV LEAD HAD DISLODGED. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22835913 ↗InjuryAug 18, 2025Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated
IT WAS REPORTED THAT LOSS OF CAPTURE WAS NOTED ON THE LEFT VENTRICULAR (LV) LEAD. ON (B)(6) 2025, DIAGNOSTIC IMAGING WAS PERFORMED, AND DISLODGEMENT WAS CONFIRMED ON THE LEAD. THE PHYSICIAN EXPLANTED AND REPLACED THE LV LEAD. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22834388 ↗InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NEW INFORMATION RECEIVED NOTES THAT THE LEADS HAD VEGETATION THAT WAS CONFIRMED VIA ECHOCARDIOGRAPHY. THERE IS NO ALLEGATION FROM THE PHYSICIAN THAT THE INFECTION WAS DUE TO THE IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 22392964 ↗MalfunctionJun 26, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE STYLET FAILED TO BE REMOVED FROM THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS NOT USED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22334181 ↗InjuryJun 16, 2025Capturing Problem; Capturing Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD. THE LV LEAD WAS CAPPED AND REPLACED. ON (B)(6) 2025. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22208936 ↗InjuryMay 30, 2025Capturing Problem; Capturing Problem
NEW INFORMATION NOTED THAT THE RIGHT VENTRICULAR LEAD AND THE LEFT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THE LV LEAD REMAINS IMPLANTED AND CONNECTED TO THE NEW DEVICE. THE RV LEAD WAS CAPPED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22118644 ↗InjuryMay 21, 2025Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated
IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD DISLODGED AND NON-CAPTURE WAS ALSO NOTED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22060561 ↗InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THEIR LEFT VENTRICULAR (LV) LEAD, RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD EXPLANTED DUE TO UNSPECIFIED ISSUES. NO PATIENT CONDITION OR FURTHER INFORMATION COULD BE OBTAINED.
Patient problems: Insufficient Information
MAUDE report 21991907 ↗
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
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page