Ellipse™ CD1411-36QRecalls & reported problems
St. Jude Medical, Inc. · Tiered-therapy cardioverter/defibrillator VVEV VVIR · Class 3 · Implant
All models of Ellipse (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Ellipse implantable defibrillator has 694 adverse event reports, with 17 deaths and 327 injuries. Many describe the device delivering shocks or pacing that patients did not need, resetting unexpectedly, and misreading heart signals; reports also mention infections and discomfort. 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
- 694
- Deaths reported
- 17
- Injuries reported
- 327
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 694 adverse event reports that list this exact device (DI 05414734507738), received between Jun 27, 2018 and Sep 10, 2026 — classified as 17 deaths, 327 injuries, 350 malfunctions.
The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (155 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
- Adverse Event Without Identified Device or Use Problem160
- Inappropriate or Unexpected Reset155
- Over-Sensing134
- Inappropriate/Inadequate Shock/Stimulation99
- Incorrect Interpretation of Signal50
- Under-Sensing32
- Communication or Transmission Problem27
- Failure to Deliver Shock/Stimulation24
Patient problems
- No Clinical Signs, Symptoms or Conditions230
- No Known Impact Or Consequence To Patient193
- Unspecified Infection108
- Discomfort40
- Therapeutic Effects, Unexpected35
- Arrhythmia27
- Insufficient Information19
- Pocket Erosion18
Recent adverse event reports
The 25 most recent of 694 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Under-Sensing
It was reported that the Implantable Cardioverter Defibrillator (ICD) and Right Ventricular (RV) lead exhibited under-sensing. No intervention was reported. The patient condition was unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720059 ↗MalfunctionAug 19, 2026Signal Artifact/Noise
It was reported that the Implantable Cardioverter Defibrillator (ICD) exhibited noise. No intervention was reported. Patient condition was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50328631 ↗MalfunctionAug 5, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50143601 ↗InjuryJul 31, 2026Inappropriate/Inadequate Shock/Stimulation
It was reported that the patient received inappropriate shock by the Implantable Cardioverter Defibrillator (ICD). No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107946 ↗InjuryJun 1, 2026Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT A REVIEW OF A REMOTE TRANSMISSION SHOWED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERING INAPPROPRIATE THERAPY. PROGRAMMING CHANGES WERE DISCUSSED BUT NOT MADE AT THIS TIME. NO PATIENT SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348844 ↗InjuryMay 29, 2026Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL INAPPROPRIATE SHOCKS FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND THE PHYSICIAN INDICATED THE WIRING WAS FAULTY AND THE ICD NEEDED TO BE REPLACED.
Patient problems: Insufficient Information
MAUDE report 25340836 ↗InjuryMay 22, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. A REMOTE TRANSMISSION SHOWED THAT THE PATIENT WAS INAPPROPRIATELY DELIVERED ANTI-TACHYCARDIA PACING BY THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO INCORRECT INTERPRETATION OF SUPRAVENTRICULAR TACHYCARDIA. NO INTERVENTION WAS PERFORMED. THE PATIENT HAD NO ADVERSE CONSEQUENCES DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25260205 ↗MalfunctionMay 8, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-SENSED T-WAVE OVERSENSING (PSTWOS). NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25126215 ↗MalfunctionApr 30, 2026Failure to Interrogate; Interrogation Problem
NEW INFORMATION RECEIVED NOTED THAT THERE WAS NO RF TELEMETRY ISSUE NOTED HOWEVER, THE ICD COULD NOT SUCCESSFULLY SEND A TRANSMISSION. THE PATIENT WAS PROVIDED WITH AN INDUCTIVE MONITOR TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25046565 ↗MalfunctionApr 21, 2026Failure to Interrogate
IT WAS REPORTED THAT A PATIENT PRESENTED WITH NO RADIOFREQUENCY TELEMETRY NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO INFORMATION REGARDING INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24945491 ↗DeathApr 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DIED DUE TO UNKNOWN CAUSES. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED.
Patient problems: Insufficient Information
MAUDE report 24917003 ↗InjuryMar 30, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT DUE TO INAPPROPRIATE SHOCK AND PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INCORRECT INTERPRETATION OF SUPRAVENTRICULAR TACHYCARDIA (SVT). NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Discomfort
MAUDE report 24720631 ↗MalfunctionMar 24, 2026Over-Sensing
IT WAS REPORTED THAT DURING A REMOTE FOLLOW-UP, THE PATIENT¿S IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) EXHIBITED MYOPOTENTIAL OVERSENSING. NO INTERVENTION WAS PERFORMED. THE PATIENT¿S CONDITION REMAINED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24683295 ↗MalfunctionMar 24, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WENT INTO BACKUP OPERATION WITH HIGH VOLTAGE THERAPIES DISABLED, CAUSED BY THE PATIENT UNDERGOING A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE WITHOUT PUTTING THE ICD IN MRI MODE. PROGRAMMING CHANGES WERE MADE TO RESET THE ICD. THE PATIENT HAD NO ADVERSE CONSEQUENCES DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680297 ↗MalfunctionMar 10, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING (PPTWOS). PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561248 ↗MalfunctionMar 9, 2026Failure to Capture
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF VENTRICULAR CAPTURE. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24553056 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ELEVATED WHITE BLOOD CELL COUNT AND WAS FOUND TO HAVE VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND THE RV LEAD WERE EXPLANTED DUE TO THE INFECTION. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Unspecified Infection
MAUDE report 24438861 ↗MalfunctionFeb 19, 2026Under-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDERSENSING. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24393108 ↗InjuryFeb 17, 2026Capturing Problem
IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED HIGH PACING IMPEDANCE. FRACTURE WAS SUSPECTED. THE LEAD WAS CAPPED ON (B)(6) 2026 AND THE DEVICE WAS EXPLANTED ON (B)(6) 2026 DUE TO HIGH CAPTURE THRESHOLDS. PATIENT STATUS POST-OPERATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24368218 ↗MalfunctionFeb 9, 2026Under-Sensing
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDER-SENSING WHICH WAS SUSPECTED TO BE DUE TO THE DEVICE¿S PROGRAMMED SETTINGS. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24299804 ↗DeathJan 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO UNKNOWN CAUSES. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD REMAINED IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 24059989 ↗InjuryJan 7, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT EXPERIENCED TACHYCARDIA AND PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW, OUT OF RANGE DEFIBRILLATION IMPEDANCE AND NO HIGH VOLTAGE OUTPUT. THE RV LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2025. ADDITIONALLY, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALSO EXPLANTED AND REPLACED FOR UNSPECIFIED REASON. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995217 ↗MalfunctionDec 30, 2025Inappropriate or Unexpected Reset; Compatibility Problem; Inappropriate or Unexpected Reset; Compatibility Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP OPERATION MODE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23931241 ↗InjuryDec 22, 2025Failure to Deliver Shock/Stimulation; Incorrect Interpretation of Signal; Failure to Deliver Shock/Stimulation; Incorrect Interpretation of Signal
IT WAS REPORTED THAT THE PATIENT WAS HAVING VENTRICULAR TACHYCARDIA WITH ONLY THE MORPHOLOGY DISCRIMINATOR TURNED ON, AND IT WAS CALLING THE RHYTHM SVT. PROGRAMMING CHANGES WERE PERFORMED AND THE VT WAS RESOLVED BY EXTERNAL SHOCK. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23864524 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE EMERGENCY DUE TO BEING VERY ILL. THE PATIENT HAD AN INFECTION RESULTING IN VEGETATION ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD AND ON THE PATIENT'S VALVES. THE ICD AND THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 23346839 ↗
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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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