Ellipse™ CD2311-36QRecalls & 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 Ellipse defibrillator is an implanted defibrillator. Many of the 124 reports describe oversensing, unexpected resets, and charging problems, and most say the patient was not affected. The reports include 3 deaths and 47 injuries. 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
- 124
- Deaths reported
- 3
- Injuries reported
- 47
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 05414734505994), received between Jun 19, 2018 and Nov 22, 2023 — classified as 3 deaths, 47 injuries, 74 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (36 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-Sensing36
- Inappropriate or Unexpected Reset17
- Inappropriate/Inadequate Shock/Stimulation12
- Adverse Event Without Identified Device or Use Problem11
- Delayed Charge Time11
- Failure to Charge11
- Under-Sensing10
- Incorrect Interpretation of Signal5
Patient problems
- No Known Impact Or Consequence To Patient60
- No Clinical Signs, Symptoms or Conditions25
- Therapeutic Effects, Unexpected10
- No Consequences Or Impact To Patient6
- Unspecified Infection5
- Arrhythmia4
- Insufficient Information4
- Dizziness3
Recent adverse event reports
The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2023Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 18197117 ↗MalfunctionOct 12, 2023Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 17927247 ↗MalfunctionMay 16, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE FOR ELECTIVE REPLACEMENT INDICATOR (ERI). UPON INTERROGATION, THE DEVICE WAS FOUND TO BE IN BACKUP OPERATION MODE WITH HIGH VOLTAGE THERAPIES DISABLED. FURTHER REVIEW INDICATED THAT THE BATTERY WAS AT END OF SERVICE (EOS) AND UNLIKELY WOULD BE RECOVERED. THE GENERAL CHANGE PROCEDURE PROCEEDED WITH NO COMPLICATIONS, AND NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16938854 ↗MalfunctionMar 31, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP MODE. DEFIBRILLATION THERAPY WAS DISABLED. THE CAUSE OF RESET WAS UNABLE TO BE DETERMINED BUT THE DEVICE WAS SUCCESSFULLY RESTORED BACK TO NORMAL. THE PATIENT WAS STABLE AND ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16657672 ↗MalfunctionMar 31, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP MODE. DEFIBRILLATION THERAPY WAS DISABLED. THE CAUSE OF RESET WAS UNABLE TO BE DETERMINED BUT THE DEVICE WAS SUCCESSFULLY RESTORED BACK TO NORMAL. THE PATIENT WAS STABLE AND ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16657622 ↗MalfunctionOct 19, 2022Over-Sensing; Over-Sensing
NEW INFORMATION RECEIVED INDICATING THAT PROGRAMMING CHANGES WERE MADE TO RESOLVE THE POST-PACED T-WAVE OVERSENSING (PPTWOS). THE PATIENT WAS STABLE, NO ADVERSE HEALTH CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15634086 ↗DeathSep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-37634. RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-37636. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO CONGESTIVE HEART FAILURE. IT WAS UNKNOWN WHETHER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR, OR ATRIAL LEAD CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15396936 ↗InjurySep 2, 2022Incorrect Measurement; Incorrect Measurement
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-22203. IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LONGEVITY WAS OVERESTIMATED BY THE PROGRAMMER. THE DEVICE WAS EXPLANTED PRIOR TO ELECTIVE REPLACEMENT INDICATOR DUE TO LONGEVITY OVERESTIMATION. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15348246 ↗MalfunctionAug 10, 2022Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, IT WAS FOUND THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15200833 ↗InjuryMay 22, 2022Incorrect Measurement; Incorrect Measurement
NEW INFORMATION RECEIVED NOTES THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14467570 ↗InjuryApr 8, 2022Under-Sensing; Under-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, IT WAS FOUND THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDER SENSING. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14060567 ↗InjuryFeb 24, 2022Pacing Asynchronously; Pacing Asynchronously
RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2022-04019. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED COMPETITIVE ATRIAL PACING AND THE ATRIAL LEAD EXHIBITED UNDER-SENSING AS WELL AS INAPPROPRIATE AUTOMATIC MODE SWITCH DUE TO NOISE OVER-SENSING. THE ICD AND THE ATRIAL LEAD WERE BOTH EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13595620 ↗MalfunctionJan 11, 2022Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 13226710 ↗MalfunctionJan 5, 2022Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 13168122 ↗InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-39787, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-39790, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-39792. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR EXPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT ATRIAL, AND TWO RIGHT VENTRICULAR LEADS, DUE TO BACTEREMIA. TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED PROBABLE LEAD VEGETATIONS. THE WERE NO PATIENT COMPLICATIONS. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Unspecified Infection
MAUDE report 13054439 ↗InjuryAug 31, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY WITH A MERLIN ON DEMAND TRANSMISSION THAT SHOWED THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE. THE CAUSE OF THE BACKUP MODE COULD NOT BE DETERMINED AND IT WAS NOTED THAT THE DEVICE HAD RECENTLY RECEIVED AN ELECTIVE REPLACEMENT INDICATOR NOTIFICATION. THEREFORE, THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE DEVICE SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12397682 ↗MalfunctionJul 28, 2021Failure to Charge; Failure to Charge
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITING AN ALERT FOR EXCEEDING THE CHARGE TIME LIMIT. NO PROGRAMMING CHANGES OR REVISIONS WERE MADE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12242433 ↗MalfunctionJun 29, 2021Tactile Prompts/Feedback; Tactile Prompts/Feedback
IT WAS REPORTED THAT THE TEST VIBRATORY ALERT BUTTON ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DID NOT ILLICIT A VIBRATION IN THE DEVICE. THE PATIENT WAS IN STABLE CONDITION AND WOULD CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12089323 ↗MalfunctionJun 22, 2021Over-Sensing; Over-Sensing
IT WAS REPORTED A PATIENT'S IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR PRESENTED WITH NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING DUE TO POST-PACED T-WAVE OVERSENSING. INTERVENTION DISCUSSED BUT NO CHANGES WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12045868 ↗MalfunctionJun 21, 2021Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE PATIENT CAME INTO THE CLINIC AND STATED THAT THEY WERE UNABLE TO SEND REMOTE MERLIN TRANSMISSIONS. UPON INTERROGATION IT WAS NOTED THAT THERE WAS AN INTERNAL RADIO FREQUENCY (RF) ERROR. NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12037428 ↗InjuryMay 27, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT WAS REQUIRED EMERGENCY MEDICAL ASSISTANCE DUE TO AN UNRELATED EVENT. IT WAS DISCOVERED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DELIVERED INAPPROPRIATE SHOCK CAUSED BY CHEST COMPRESSIONS PERFORMED BY EMERGENCY MEDICAL PERSONNEL. NO INTERVENTIONS WERE MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11897951 ↗InjuryApr 23, 2021Delayed Charge Time; Delayed Charge Time
NEW INFORMATION RECEIVED NOTES THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED ON (B)(6) 2021. THE PATIENT WAS IN STABLE CONDITION BEFORE, DURING AND AFTER THE PROCEDURE..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11718509 ↗MalfunctionApr 14, 2021Over-Sensing; Over-Sensing
IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET TRANSMISSION, POST-PACED T-WAVE OVERSENSING WAS OBSERVED. PROGRAMMING CHANGES WERE SUGGESTED. THE PHYSICIAN OPTED TO MONITOR AT THIS TIME. THE PATIENT¿S CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11665560 ↗MalfunctionMar 30, 2021Under-Sensing; Under-Sensing
IT WAS REPORTED THAT INTERMITTENT R WAVE UNDERSENSING DURING AN EPISODE OF NON SUSTAINED VENTRICULAR TACHYCARDIA WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE EPISODE WAS LESS THAN 5 SEC. IN DURATION AND A SINGLE R WAVE DROP OUT WAS OBSERVED. THERE WAS NO HARM OR DELAY IN THERAPY AS THE EPISODE SELF TERMINATED SPONTANEOUSLY BACK TO SINUS RHYTHM. PROGRAMMING CHANGES TO SENSITIVITY WERE MADE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: Arrhythmia
MAUDE report 11591920 ↗MalfunctionMar 24, 2021Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW UP. IT WAS NOTED THAT THE DEVICE WAS POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE PATIENT DID NOT RECEIVE THERAPY DURING THE OVERSENSING. PROGRAMMING CHANGES WERE DISCUSSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11564190 ↗
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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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