Quartet™ 1458QL (UDI 05414734510226)Recalls & 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

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734510226), received between Sep 15, 2019 and Jan 16, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

Most reported problems

Device problems

Device Dislodged or Dislocated2
Separation Failure1

Patient problems

No Known Impact Or Consequence To Patient3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryJan 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR A THRESHOLD TEST AND THE LV LEAD WAS FOUND TO BE PULLED VIA CHEST X-RAY INTO THE POCKET. PRIOR TO THIS EVENT, THERE WERE EPISODES OF A-FIB WITH RVR WHERE THE PATIENT GOT SHOCKED SEVERAL TIMES. THE DEVICE WAS REPROGRAMMED FOR RV ONLY GIVEN THE LV LEAD BEING DISLODGED. DEVICE AND LEAD REMAINS IMPLANTED. RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020-00452.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9599391 ↗
InjuryDec 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT FOLLOWING AN ATTEMPT AT CARDIOPULMONARY RESUSCITATION (CPR), THE LEFT VENTRICULAR LEAD DISLODGED INTO THE MAIN CORONARY SINUS. THE LEAD WAS EXTRACTED AND REPLACED. THERE WERE NO COMPLAINTS ON THE DEFIBRILLATOR WHICH WAS REPLACED DURING THE LEAD EXTRACTION. NO FURTHER INFORMATION WAS AVAILABLE. THE PATIENT WAS STABLE AND RECOVERING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9527381 ↗
MalfunctionSep 15, 2019Separation Failure; Separation Failure
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IMPLANT PROCEDURE. DURING THE PROCEDURE, THE LEFT VENTRICULAR LEAD WAS UNABLE TO EXTEND OUT OF THE INNER GUIDE SHEATH AND WAS UNABLE TO BE REMOVED. THE LEFT VENTRICULAR LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9060624 ↗

Device details

UDI-DI	`05414734510226`
Brand	Quartet™
Model	1458QL
Company	St. Jude Medical, Inc.
Product code	NIK · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Oct 6, 2025

Device type (GMDN): Endocardial/interventricular septal pacing lead

An implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.

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All Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices →

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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