Quartet™ 1458QL (UDI 05414734510202)Recalls & reported problems
St. Jude Medical, Inc. · Left Heart Lead · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is a St. Jude Medical Quartet 1458QL left heart lead, the wire that links an implanted heart resynchronization defibrillator (CRT-D) to the heart's left ventricle. The 44 reports mostly describe the lead shifting out of position, failing to pace or sense the heart, or picking up high thresholds, often alongside infection at the implant site that led to removing the whole device system. There were 31 injuries and no deaths, 13 malfunctions, and 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
- 44
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 05414734510202), received between Aug 13, 2018 and Mar 17, 2026 — classified as 31 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem14
- Device Dislodged or Dislocated14
- Failure to Capture8
- Therapy Delivered to Incorrect Body Area6
- Capturing Problem4
- Break3
- High impedance3
- Failure to Advance2
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Unspecified Infection14
- Discomfort6
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient2
- Heart Failure1
- Septic Shock1
- Twiddlers Syndrome1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Capturing Problem
IT WAS REPORTED THAT THERE WAS AN EVENT OF LEFT VENTRICULAR (LV) LEAD HIGH CAPTURE THRESHOLDS. ON (B)(6) 2026, THE LEAD WAS CAPPED AND REPLACED AND THE SURGERY CONCLUDED SUCCESSFULLY. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616305 ↗InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH LEADS VEGETATION. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM DUE TO INFECTION. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: Unspecified Infection
MAUDE report 24401814 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH REDNESS AND SWELLING AT THE DEVICE IMPLANT SITE, DUE TO INFECTION. VEGETATION WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT THE ENTIRE CARDIAC PACING SYSTEM, INCLUDING THE PACEMAKER, LEFT VENTRICULAR (LV) LEAD, AND RIGHT VENTRICULAR (RV) LEAD, ON (B)(6) 2026. A NEW SYSTEM WAS SUBSEQUENTLY REIMPLANTED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Unspecified Infection
MAUDE report 24265411 ↗MalfunctionJan 29, 2026Device Sensing Problem; No Apparent Adverse Event
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR INITIAL IMPLANT PROCEDURE. THE LEFT VENTRICULAR (LV) LEAD WAS NOT SENSING CORRECTLY, AND THIS LV LEAD WAS NOT USED. ADDITIONALLY, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT USED DUE TO AN UNKNOWN REASON. THE PHYSICIAN COMPLETED THE PROCEDURE USING A DIFFERENT ICD AND LV LEAD. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215151 ↗InjuryJan 1, 2026Failure to Capture; Over-Sensing; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DISCOMFORT DUE TO PHRENIC NERVE STIMULATION (PNS). REMOTE TRANSMISSION REVEALED THAT THE LEFT VENTRICULAR (LV) LEAD WAS DISLODGED AND DISPLAYING FIBRILLATION WAVES ON THE PRESENTING RHYTHM. X-RAY CONFIRMED THAT THE LV LEAD HAD PULLED BACK TO THE RIGHT ATRIUM. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Discomfort
MAUDE report 23940856 ↗MalfunctionNov 18, 2025Failure to Advance; Failure to Advance
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED PROCEDURE TO UPGRADE FROM A DUAL-CHAMBER PACEMAKER TO A CRT-P SYSTEM. DURING THE PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD COULD NOT BE ADVANCED BEYOND THE TIP OF THE DELIVERY CATHETER. MULTIPLE ATTEMPTS WERE MADE BY REPLACING THE LEAD AND CATHETER, BUT ALL WERE UNSUCCESSFUL. ULTIMATELY, THE PHYSICIAN DECIDED TO CHANGE THE APPROACH TO CONDUCTION SYSTEM PACING, WHICH WAS COMPLETED SUCCESSFULLY. THE PATIENT REMAINED STABLE AND ASYMPTOMATIC THROUGHOUT THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23585050 ↗InjurySep 17, 2025Failure to Capture; Failure to Capture
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD WHICH RESULTED IN FAILURE TO CAPTURE. THE LV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23070059 ↗InjuryJun 20, 2025High impedance; Capturing Problem; High impedance; Capturing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A GENERATOR CHANGE PROCEDURE. UPON INTERROGATION PRIOR TO PROCEDURE, IT WAS NOTED THAT THE LEFT-VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD. AS A RESOLUTION THE LV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22303282 ↗InjuryJun 20, 2025Capturing Problem; Capturing Problem
IT WAS REPORTED THAT DURING DEVICE CHANGEOUT PROCEDURE ON (B)(6) 2025, THE LEFT VENTRICLE (LV) LEAD EXHIBITED HIGH THRESHOLD. SUBSEQUENTLY, THE LV LEAD WAS CAPPED AND REPLACED DURING THE SAME PROCEDURE. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22295858 ↗MalfunctionMay 30, 2025Failure to Advance; Failure to Advance
DURING ATTEMPTED IMPLANT, THE LEFT VENTRICULAR (LV) LEAD COULD NOT BE INSERTED INTO THE GUIDEWIRE. A DIFFERENT GUIDEWIRE WAS USED; THE LV LEAD COULD NOT BE ADVANCED. A DIFFERENT LV LEAD WAS SUCCESSFULLY IMPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22119174 ↗InjuryMay 5, 2025Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON EXAMINATION, IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED PHRENIC NERVE STIMULATION. THE LV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Discomfort
MAUDE report 21958825 ↗MalfunctionDec 31, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A SCHEDULED IMPLANT PROCEDURE. DURING PROCEDURE, INSULATION BREACH BY A GUIDEWIRE WAS NOTED. THE LEAD WAS REMOVED AND REPLACED. THE PATIENT HAD NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21046417 ↗InjuryOct 14, 2024Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON PHYSICAL EXAMINATION, IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED DIAPHRAGMATIC STIMULATION. CHEST X-RAY CONFIRMED THAT THE LV LEAD WAS DISLODGED. THE LV LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2024. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: Discomfort
MAUDE report 20440145 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER:2017865-2024-37107, RELATED MANUFACTURER REFERENCE NUMBER:2017865-2024-37108, RELATED MANUFACTURER REFERENCE NUMBER:2017865-2024-37109. IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH AN INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE PHYSICIAN EXPLANTED AND REPLACED THE ENTIRE SYSTEM ¿ IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD), RIGHT VENTRICULAR LEAD, ATRIAL LEAD AND LEFT VENTRICULAR LEAD DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Unspecified Infection
MAUDE report 18994333 ↗InjuryFeb 6, 2024Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED FAILURE TO CAPTURE. AN X-RAY WAS PERFORMED AND IT WAS DISCOVERED THE LEAD WAS DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS DISCHARGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18655472 ↗InjuryAug 31, 2023Failure to Capture; High impedance; Failure to Capture; High impedance
IT WAS REPORTED, THAT THE PATIENT PRESENTED TO THE CLINIC FOR A SCHEDULED FOLLOW UP. UPON INTERROGATION OF THE PULSE GENERATOR, IT WAS NOTED, THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE AND HIGH PACING IMPEDANCE MEASUREMENT. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2023. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17666772 ↗InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-39297. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-39298. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-39299. IT WAS REPORTED THAT THE PATIENT'S FULL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WAS EXPLANTED DUE TO INFECTION. THE SYSTEM WAS RE-IMPLANTED UPON CLEARING OF THE INFECTION ON (B)(6) 2023. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: Unspecified Infection
MAUDE report 17624840 ↗MalfunctionJul 11, 2023Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area
IT WAS REPORTED THAT THE PATIENT PRESENTED TO IN CLINIC FOLLOW UP WITH DISCOMFORT. THE LEFT VENTRICULAR LEAD WAS DELIVERING UNINTENDED EXTRA-CARDIAC STIMULATION. THE LEAD WAS DEACTIVATED. THE PATIENT WAS STABLE.
Patient problems: Discomfort
MAUDE report 17303234 ↗InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-17149, RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-17148, RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-17147. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR EXPLANT DUE TO AN INFECTION OF UNKNOWN ORIGIN WITH WHAT APPEARED TO BE LEAD VEGETATIONS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT ATRIAL, RIGHT VENTRICULAR, AND LEFT VENTRICULAR LEADS WERE EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Unspecified Infection
MAUDE report 16710335 ↗MalfunctionDec 2, 2022Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-47524. IT WAS REPORTED A PATIENT PRESENTED WITH DIAPHRAGMATIC STIMULATION ON THE LEFT VENTRICULAR LEAD. UPON FURTHER ANALYSIS IN CLINIC, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED IN BACKUP VVI MODE. PROGRAMMING CHANGES WERE MADE TO ADDRESS BOTH ANOMALIES. THE PATIENT WAS STABLE.
Patient problems: Discomfort
MAUDE report 15906548 ↗InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-11043. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFECTION AND VEGETATION ON RIGHT ATRIUM PRIOR TO THE LEAD EXTRACTION PROCEDURE. THE SPECIMEN CULTURES WERE TESTED FOR BACTERIAL INFECTION. THE PHYSICIAN EXPLANTED THE SYSTEM ¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR LEAD, LEFT VENTRICULAR LEAD, AND ATRIAL LEAD. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Unspecified Infection
MAUDE report 14545288 ↗InjuryMay 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-10449. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM. DURING DEVICE INTERROGATION, IT WAS DISCOVERED THAT THE LEFT VENTRICULAR(LV) AND RIGHT VENTRICULAR(RV) LEADS WERE DISLODGED. THE DISLODGMENT WAS CONFIRMED VIA X-RAY IMAGING. THE PATIENT PRESENTED TO A SCHEDULED LEAD REVISION. DURING THE PROCEDURE, THE RV LEAD COULD NOT BE RE-POSITIONED AS THE HELIX WOULD NOT EXTEND. THE RV AND LV LEADS WERE EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14438337 ↗InjuryMar 21, 2022Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A FAILURE TO CAPTURE. DURING A CHEST X-RAY, IT WAS OBSERVED THAT THE LV LEAD WAS DISLODGED. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13840744 ↗InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-04819. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-04820. IT WAS REPORTED A PATIENT PRESENTED WITH A POCKET INFECTION. THEIR SYSTEM WAS EXPLANTED IN A PROCEDURE ON (B)(6) 2022. POST-PROCEDURE THE PATIENT WAS STABLE.
Patient problems: Unspecified Infection
MAUDE report 13690726 ↗MalfunctionFeb 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
RELATED MANUFACTURER NUMBER: 2017865-2022-02579. RELATED MANUFACTURER NUMBER: 2017865-2022-02580. IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL LEAD EXHIBITED NOISE. DURING THE LEAD REPLACEMENT PROCEDURE, THE RIGHT VENTRICULAR AND LEFT VENTRICULAR LEADS DISLODGED. THE RIGHT ATRIAL LEAD WAS REMOVED AND REPLACED. THE RIGHT VENTRICULAR LEAD AND LEFT VENTRICULAR LEAD WERE REMOVED AND REIMPLANTED ON (B)(6) 2022. THE PATIENT WAS DISCHARGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13447175 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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