Ellipse™ CD2411-36CRecalls & reported problems
St. Jude Medical, Inc. · Tiered-therapy cardioverter/defibrillatorVVED DDDR · Class 3 · Implant
All models of Ellipse (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Ellipse implantable defibrillator is a heart device that monitors heartbeats and delivers shocks or pacing. Of its 569 reports, 391 describe malfunctions and 161 describe injuries, and 17 deaths are recorded. Most malfunction reports describe the device misreading heart signals, sometimes with unexpected resets or shocks. Recent reports describe sensing errors found during follow-up checks, with programming changes made. 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
- 569
- Deaths reported
- 17
- Injuries reported
- 161
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 569 adverse event reports that list this exact device (DI 05414734507585), received between Jun 18, 2018 and Jul 6, 2026 — classified as 17 deaths, 161 injuries, 391 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (237 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
- Over-Sensing237
- Adverse Event Without Identified Device or Use Problem68
- Inappropriate or Unexpected Reset66
- Inappropriate/Inadequate Shock/Stimulation56
- Under-Sensing34
- Incorrect Interpretation of Signal31
- Failure to Interrogate26
- Signal Artifact/Noise21
Patient problems
- No Clinical Signs, Symptoms or Conditions223
- No Known Impact Or Consequence To Patient193
- Unspecified Infection49
- No Consequences Or Impact To Patient21
- Therapeutic Effects, Unexpected19
- Arrhythmia15
- Discomfort14
- Death13
Recent adverse event reports
The 25 most recent of 569 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2026Under-Sensing
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDERSENSING. NO INTERVENTION WAS REPORTED. PATIENT CONDITION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25727746 ↗MalfunctionJun 30, 2026Failure to Deliver Shock/Stimulation
IT WAS REPORTED THAT A REVIEW OF A REMOTE TRANSMISSION SHOWING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT DELIVER DEVICE THERAPY. THE PATIENT PRESENTED TO THE CLINIC, AND PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS ASYMPTOMATIC.
Patient problems: Arrhythmia
MAUDE report 25664871 ↗MalfunctionJun 26, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR FOLLOW UP. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LVAD (LEFT VENTRICULAR ASSIST DEVICE) OVERSENSING. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25642756 ↗MalfunctionJun 25, 2026Sensing Intermittently
IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INTERMITTENT SENSING. PROGRAMMING CHANGES WERE MADE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25622831 ↗MalfunctionJun 23, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset
NEW INFORMATION INDICATES THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS OPERATING IN BACKUP MODE DUE TO THE MAGNETIC RESONANCE IMAGING (MRI) SCAN BEING PERFORMED WITHOUT THE ICD BEING PROGRAMMED TO MRI MODE. PROGRAMMING CHANGES WERE MADE AND THE ICD WAS RESTORED. PATIENT¿S CONDITION WAS NOT KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598025 ↗MalfunctionJun 15, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T-WAVE OVERSENSING. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25498329 ↗MalfunctionMay 29, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. IT WAS DISCOVERED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE DISCUSSED, BUT NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25340482 ↗MalfunctionMay 18, 2026Under-Sensing
IT WAS REPORTED THAT VENTRICULAR UNDERSENSING WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) VIA REVIEW OF A REMOTE TRANSMISSION. PROGRAMMING CHANGES WERE DISCUSSED BUT NOT MADE AT THIS TIME. NO PATIENT CONDITION WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25211000 ↗DeathMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSES OF DEATH WAS A VT ABLATION AND PNEUMONECTOMY. A FEW DAYS LATER THE PATIENT BECAME SEPTIC AND EXPIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178376 ↗MalfunctionApr 14, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FAR P-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE TO RESOLVE THE ISSUE, AND THE PATIENT REMAINED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24876991 ↗InjuryApr 14, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POSSIBLE EARLY BATTERY DEPLETION. THE PRODUCT WAS EXPLANTED AND SUCCESSFULLY REPLACED. PATIENT STATUS WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874910 ↗MalfunctionApr 13, 2026Over-Sensing
IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FAR FIELD P WAVE OVERSENSING. NO INTERVENTION WAS MADE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24853797 ↗MalfunctionFeb 24, 2026Over-Sensing
IT WAS REPORTED THAT PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FAR P WAVE OVER-SENSING. PROGRAMMING CHANGES WERE MADE. PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24425533 ↗MalfunctionJan 16, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED CROSSTALK OVER-SENSING. PROGRAMMING CHANGES WERE SUGGESTED. NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101267 ↗InjuryJan 5, 2026Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCK. THE DEVICE WAS EXPLANTED. PATIENT CONDITION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23959753 ↗InjuryDec 22, 2025Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCK DUE TO INCORRECT INTERPRETATION OF SIGNAL. THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23866330 ↗MalfunctionDec 9, 2025Intermittent Capture; Intermittent Capture
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INTERMITTENT CAPTURE. NO INTERVENTION WAS PERFORMED. THE PATIENT HAD NO CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23761217 ↗MalfunctionNov 26, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED POST-PACED T-WAVE OVERSENSING (PPTWOS) ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE DISCUSSED, NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23659498 ↗MalfunctionNov 3, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FAR R WAVE OVERSENSING RESULTING IN INAPPROPRIATE MODE SWITCH (AMS). NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23457748 ↗InjuryOct 27, 2025Failure to Deliver Shock/Stimulation; Under-Sensing; Failure to Deliver Shock/Stimulation; Under-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAILED TO DELIVER SHOCK DUE TO UNDERSENSING, CAUSING THE PATIENT TO HAVE VENTRICULAR FIBRILLATION. PROGRAMMING CHANGES WERE MADE. THE PATIENT HAD NO CONSEQUENCES.
Patient problems: Arrhythmia
MAUDE report 23391082 ↗MalfunctionSep 19, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT ATRIAL OVERSENSING WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD. NO CHANGES OR INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097991 ↗InjuryAug 27, 2025Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT A PATIENT PRESENTED WITH INAPPROPRIATE SHOCK NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO INFORMATION REGARDING INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 22906933 ↗InjuryAug 21, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE DEVICE WAS IN BACKUP VVI MODE. THE DEVICE HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6) 2025. THE DEVICE WAS PARTIALLY RESTORED FROM BVVI POST-OP TO TURN TACHY THERAPY OFF. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22862107 ↗MalfunctionAug 12, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WENT INTO BACKUP OPERATION. NO INTERVENTION WAS PERFORMED. THE PATIENT HAD NO CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22784856 ↗InjuryJul 28, 2025Over-Sensing; No Apparent Adverse Event; Over-Sensing; No Apparent Adverse Event
NEW INFORMATION NOTES THAT ON (B)(6) 2025, THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED. DEVICE INTERROGATION SHOWED OVERSENSING ON IMPLANTABLE DEFIBRILLATION CARDIOVERTER (ICD). THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22638520 ↗
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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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