Ellipse™ CD2411-36QRecalls & reported problems
St. Jude Medical, Inc. · DR Implantable Cardioverter Defibrillator VVED 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 Medical Ellipse DR implantable defibrillator monitors heart rhythm and can deliver shocks. The 1,495 reports most often describe the device reading extra signals, unexpected resets, and inappropriate shocks, and some mention infections. The reports list 42 deaths and 509 injuries. Reports in the last 12 months number 39, compared with 81 in the 12 months before. 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
- 1,498
- Deaths reported
- 42
- Injuries reported
- 509
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,498 adverse event reports that list this exact device (DI 05414734507615), received between Jun 11, 2018 and Sep 30, 2026 — classified as 42 deaths, 509 injuries, 947 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (592 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-Sensing592
- Adverse Event Without Identified Device or Use Problem237
- Inappropriate or Unexpected Reset189
- Inappropriate/Inadequate Shock/Stimulation183
- Incorrect Interpretation of Signal104
- Under-Sensing87
- Signal Artifact/Noise51
- Pacing Problem46
Patient problems
- No Clinical Signs, Symptoms or Conditions629
- No Known Impact Or Consequence To Patient386
- Unspecified Infection155
- Therapeutic Effects, Unexpected62
- Arrhythmia59
- No Consequences Or Impact To Patient58
- Discomfort52
- Insufficient Information45
Recent adverse event reports
The 25 most recent of 1,498 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951236 ↗MalfunctionSep 17, 2026Over-Sensing
Patient problems: Insufficient Information
MAUDE report 50797110 ↗MalfunctionSep 15, 2026Intermittent Capture
Patient problems: Insufficient Information
MAUDE report 50774222 ↗MalfunctionSep 14, 2026Over-Sensing; Pacing Problem
It was reported that a potential myopotentials oversensing resulting in episode of automatic mode switch (AMS) was observed via a review of remote transmission. No intervention was made at this time. No patient condition was reported.
Patient problems: Insufficient Information
MAUDE report 50753777 ↗MalfunctionSep 8, 2026Signal Artifact/Noise
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677630 ↗MalfunctionAug 16, 2026Over-Sensing; Pacing Problem
It was reported that the patient presented remotely via Merlin.net. It was noted that the Implantable Cardioverter Defibrillator (ICD) exhibited Far R-wave Oversensing resulting in inappropriate mode switch (AMS). No intervention was performed. The patient's condition is unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50268017 ↗MalfunctionAug 13, 2026Failure to Capture
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited loss of capture. No additional information was received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240243 ↗MalfunctionAug 12, 2026Failure to Capture
It was reported that the patient presented remotely via merlin.net. Review of transmission revealed that the Implantable Cardioverter Defibrillator (ICD) exhibited loss of capture. No intervention was performed, and the patient will continue to be monitored. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217073 ↗MalfunctionJul 31, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105053 ↗MalfunctionJul 6, 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 POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE, AND THE PATIENT DID NOT EXPERIENCE ANY CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25725406 ↗MalfunctionJun 16, 2026Inappropriate or Unexpected Reset; Compatibility Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PUT INTO MRI MODE PRIOR TO PROCEDURE BUT WAS NOT TAKEN OUT OF MRI MODE AFTERWARDS, CAUSING THE ICD TO INAPPROPRIATELY GO INTO BACKUP OPERATION. PROGRAMMING CHANGES WERE MADE TO RESET THE DEVICE. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25519463 ↗MalfunctionMay 26, 2026Data Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DISPLAYED AN ERROR MESSAGE. PROGRAMMING CHANGES WERE PERFORMED TO RESTORE THE DEVICE BACK TO CHRONIC SETTINGS. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25290408 ↗InjuryMay 21, 2026Premature Discharge of Battery
IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE PRODUCT WAS EXPLANTED AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244076 ↗InjuryMay 13, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT A PATIENT PRESENTED WITH INAPPROPRIATE ANTI-TACHYCARDIA PACING NOTED DUE TO INCORRECT INTERPRETATION OF SIGNAL. PROGRAMMING CHANGES WERE RECOMMENDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25165131 ↗MalfunctionMay 8, 2026Over-Sensing
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING (PPTWOS). NO INTERVENTION WAS REPORTED AND PATIENT STATUS WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122678 ↗InjuryMay 5, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE DEVICE DELIVERED INAPPROPRIATE SHOCKS DUE TO AN INCORRECT INTERPRETATION OF SIGNAL. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089699 ↗MalfunctionApr 29, 2026Under-Sensing
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INTERMITTENT ATRIAL UNDER-SENSING. NO INTERVENTION WAS REPORTED, AND THE PATIENT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034888 ↗MalfunctionApr 23, 2026Signal Artifact/Noise; Over-Sensing
IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972166 ↗MalfunctionApr 14, 2026Over-Sensing; Pacing Asynchronously
IT WAS REPORTED THAT A PATIENT PRESENTED WITH OVER-SENSING OF COMPETITIVE ATRIAL PACING NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO PROGRAMMING OR INTERVENTION WAS PLANNED OR PERFORMED. NO INFORMATION WAS PROVIDED REGARDING PATIENT CONSEQUENCES BUT THE PATIENT WAS PRESUMED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874920 ↗MalfunctionApr 11, 2026Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN BACKUP VVI MODE UPON INTERROGATION. NO INTERVENTION WAS PERFORMED, AND THE PATIENT'S STATUS WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24848010 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO PATIENT DISCOMFORT. THE PATIENT REMAINED STABLE.
Patient problems: Discomfort
MAUDE report 24820933 ↗MalfunctionMar 30, 2026Failure to Capture
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED LOSS OF CAPTURE. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714934 ↗MalfunctionMar 9, 2026Under-Sensing
NEW INFORMATION RECEIVED NOTES THE PATIENT WAS ASYMPTOMATIC, PROGRAMMING CHANGES WERE MADE, THE PATIENT WAS TO CONTINUE WITH FOLLOW UP IN CLINIC AND WAS STABLE BEFORE, DURING AND AFTER THE EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24548360 ↗InjuryFeb 20, 2026Inappropriate/Inadequate Shock/Stimulation
NEW INFORMATION RECEIVED NOTES THAT THE EPISODES OF INAPPROPRIATE SHOCK DELIVERED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WERE NOTED IN CLINIC. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404967 ↗InjuryFeb 20, 2026Unexpected Mode Switch
NEW INFORMATION RECEIVED NOTES THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403183 ↗
Other Pulse generator, permanent, implantable devices
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- Fortify Assura™ CD2357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable63 deaths3,571 reports
- Advisa DR MRI™ SureScan® A2DR01Medtronic, Inc. · Pulse generator, permanent, implantable51 deaths2,298 reports
- Fortify Assura™ CD1357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable35 deaths1,933 reports
- Fortify Assura™ CD2357-40CSt. Jude Medical, Inc. · Pulse generator, permanent, implantable25 deaths1,378 reports
- Accent® DR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable73 deaths1,370 reports
- Edora 8 DR-T 407145BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable10 deaths982 reports
- Zephyr™ XL DRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable24 deaths944 reports
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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