Ellipse™ CD1411-36CRecalls & 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 is an implantable defibrillator. Its 250 reports often describe the device misreading heart signals or resetting unexpectedly, and some describe inappropriate shocks and infections that led to removal. The reports include 83 injuries and 14 deaths. Reports dropped from 25 in the previous 12 months to 10 in the most recent 12 months. 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
- 248
- Deaths reported
- 14
- Injuries reported
- 82
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 248 adverse event reports that list this exact device (DI 05414734507707), received between Jun 11, 2018 and Aug 26, 2026 — classified as 14 deaths, 82 injuries, 152 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (66 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-Sensing66
- Inappropriate or Unexpected Reset43
- Adverse Event Without Identified Device or Use Problem42
- Inappropriate/Inadequate Shock/Stimulation26
- Incorrect Interpretation of Signal14
- Under-Sensing13
- High impedance12
- Signal Artifact/Noise12
Patient problems
- No Clinical Signs, Symptoms or Conditions88
- No Known Impact Or Consequence To Patient72
- Unspecified Infection25
- Arrhythmia11
- Discomfort11
- Insufficient Information11
- Therapeutic Effects, Unexpected10
- Death9
Recent adverse event reports
The 25 most recent of 248 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50464926 ↗MalfunctionJul 8, 2026Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN BACK-UP MODE DUE TO A HARDWARE RESET. NO INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25752046 ↗MalfunctionJun 22, 2026Incorrect Measurement
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED DAMAGE ALERT SUSPECTED TO BE A FALSE ALERT CAUSED BY AN UNRELATED SURGERY. NO CHANGES OR INTERVENTIONS WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578301 ↗MalfunctionJun 8, 2026Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED WITH POST-SENSED T-WAVE OVER-SENSING NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. PROGRAMMING CHANGES WERE RECOMMENDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436816 ↗MalfunctionMay 19, 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 EPISODES OF POST-SENSED T-WAVE OVERSENSING (PSTWOS). NO INTERVENTION WAS REPORTED AND THE PATIENT WILL BE FURTHER MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25220139 ↗MalfunctionFeb 24, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS DISCOVERED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSING. NO INTERVENTION WAS PERFORMED, AND THE PATIENT'S STATUS WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24435983 ↗InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH AN INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM ¿ IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR AND RIGHT VENTRICULAR LEAD DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Unspecified Infection
MAUDE report 24032661 ↗MalfunctionDec 9, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT UNSPECIFIED VENTRICULAR OVERSENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).
Patient problems: Insufficient Information
MAUDE report 23763768 ↗InjuryOct 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED FOR UNKNOWN REASONS. THE PATIENT'S CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437448 ↗InjuryOct 22, 2025Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INAPPROPRIATE INTERPRETATION OF SUPRAVENTRICULAR TACHYCARDIA SIGNALS WHICH CAUSED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK TO BE DELIVERED. NO INTERVENTION WAS PERFORMED. THE PATIENT'S CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357375 ↗MalfunctionSep 15, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED WITH OVER-SENSING OF NOISE NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. CORRECTIVE PROGRAMMING CHANGES WERE RECOMMENDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23059403 ↗InjurySep 5, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Capturing Problem; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Capturing Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE SHOCK THERAPY. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNSPECIFIED OVERSENSING AND HIGH CAPTURE THRESHOLD. THE ICD AND THE RV LEAD WERE EXPLANTED AND REPLACED. THE PATIENT'S CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22986417 ↗InjuryAug 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED A VARYING HIGH VOLTAGE IMPEDANCE AND INSULATION DAMAGE. THE RV LEAD WAS CAPPED ON (B)(6) 2025, AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.
Patient problems: Insufficient Information
MAUDE report 22842818 ↗DeathAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT DECEASED FOLLOWING AN UNRELATED PROCEDURE. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 22787797 ↗InjuryAug 11, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED AN INAPPROPRIATE SHOCK. THE PATIENT HAD RECENTLY RECEIVED A LEFT VENTRICULAR ASSIST DEVICE (LVAD), CAUSING ELECTROMAGNETIC INTERFERENCE (EMI) THAT LED TO OVERSENSING, AND RESULTING IN THE INAPPROPRIATE SHOCK. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS UNKNOWN POST INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22772710 ↗MalfunctionAug 1, 2025Data Problem; Data Problem
IT WAS REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22692852 ↗InjuryJul 29, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT AS A RESOLUTION THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: Discomfort
MAUDE report 22646288 ↗MalfunctionJun 25, 2025Tactile Prompts/Feedback; Tactile Prompts/Feedback
IT WAS REPORTED THAT THE VIBRATORY ALERT WOULD NOT VIBRATE WHEN ATTEMPTED TO TEST IT IN THE CLINIC. THE ISSUE WAS NOT RESOLVED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22327415 ↗DeathJun 16, 2025Failure to Deliver Shock/Stimulation; Under-Sensing; Failure to Deliver Shock/Stimulation; Under-Sensing
IT WAS REPORTED THAT THE PATIENT PASSED AWAY (B)(6) 2025 ALLEGEDLY DUE TO FAILURE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO DETECT ARRHYTHMIA AND DELIVER SHOCK, WHICH REPORTEDLY COULD HAVE PREVENTED CARDIAC ARREST.
Patient problems: Arrhythmia
MAUDE report 22215926 ↗MalfunctionJun 7, 2025Failure to Interrogate; Improper or Incorrect Procedure or Method; Failure to Interrogate; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE EMERGENCY ROOM FOLLOWING A VENTRICULAR TACHYCARDIA (VT) STORM. IT WAS INITIALLY SUSPECTED BY EMERGENCY SERVICES (ES) THAT THE MAGNET PLACED OVER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT INHIBIT THERAPY AND THAT THE PATIENT CONTINUED TO RECEIVE SHOCK FROM THE ICD. EXAMINATION OF THE RECORDED ELECTROGRAM SHOWED THE MAGNET WAS PLACED AND THERAPY WAS INHIBITED APPROPRIATELY. THE ELECTROPHYSIOLOGIST BELIEVED THE ES PHYSICIAN WAS NOT PLACING THE MAGNET APPROPRIATELY, BUT RECORDED ELECTROCARDIOGRAM SHOWED MARKERS WITH MAGNET PLACEMENT AND NO FURTHER SHOCKS. ALL SHOCKS WERE APPROPRIATE FOR VENTRICULAR TACHYCARDIA (VT) THE PATIENT WAS STABLE AND IN A VT STORM. THE PATIENT'S SYMPTOMS WERE NOT FROM VT BUT FROM RECEIVING MULTIPLE APPROPRIATE SHOCKS WITHIN AN HOUR. NO FAILURE OF THE DEVICE WAS SUSPECTED, AND ALL THERAPY WAS APPROPRIATE AS PROGRAMMED. NO PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS FLOWN TO A DIFFERENT FACILITY FOR VT TREATMENT AND ABLATION. THE PATIENT WAS STABLE.
Patient problems: Discomfort
MAUDE report 22163424 ↗DeathMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE PATIENT DIED OF A CARDIAC ARREST. THE WIFE WAS CONCERNED THE PATIENT'S TRANSMITTER ALLEGEDLY DID NOT ALERT OF A CARDIAC ARREST AND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS DEFECTIVE. INFORMATION RECEIVED SUGGESTS THE PATIENT EXPERIENCED A FALL BACKWARDS AS HE GOT UP ON (B)(6) 2025. 911 WAS CALLED AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WHERE HE PASSED AWAY (B)(6) 2025. INFORMATION RECEIVED FROM THE FOLLOWING CLINIC INDICATES THE PATIENT'S LAST IN PERSON FOLLOW UP WITH THEIR PHYSICIAN WAS (B)(6) 2024, AND SYSTEM INTERROGATION WAS NORMAL. THE PHYSICIAN TRAVELLED OUT OF TOWN FOR THE VISIT. THE PATIENT WAS DUE FOR A YEARLY IN PERSON VISIT (B)(6) 2025 BUT DID NOT PRESENT FOR THE APPOINTMENT. THE PATIENT WAS ALSO BEING MONITORED REMOTELY AT THE FACILITY'S REMOTE MONITORING CLINIC. THE LAST REMOTE TRANSMISSION RECEIVED AND CHECKED BY THE PHYSICIAN FROM THE REMOTE MONITORING CLINIC WAS DATED (B)(6) 2024. THE PATIENT¿S PRESENTING RHYTHM WAS VENTRICULAR FIBRILLATION WITH VENTRICULAR TACHYCARDIA (VF/VT), BATTERY LONGEVITY 6.5 YRS, THE DEVICE/SYSTEM FUNCTION WAS STABLE PE
Patient problems: Arrhythmia
MAUDE report 22028945 ↗MalfunctionApr 22, 2025Intermittent Capture; Intermittent Capture
IT WAS REPORTED THAT A PATIENT PRESENTED WITH INTERMITTENT CAPTURE NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21882845 ↗MalfunctionApr 17, 2025Over-Sensing; Over-Sensing
NEW INFORMATION RECEIVED INDICATED PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21861108 ↗InjuryMar 25, 2025Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REMOTE FOLLOW UP VIA MERIN.NET. A REVIEW OF THE TRANSMISSION SHOWED THAT INAPPROPRIATE HIGH VOLTAGE (HV) THERAPY WAS DELIVERED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) WAS ATTRIBUTED TO MISDIAGNOSIS OF SUPRAVENTRICULAR TACHYCARDIA. SUBSEQUENT PROGRAMMING INTERVENTIONS WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21690892 ↗MalfunctionMar 4, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE DUE TO EVENT QUEUE OVERFLOW RELATED RESET. THE ICD WAS ABLE TO RESET TO NORMAL SETTING BY PROGRAMMING INTERVENTION. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21515639 ↗
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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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