EllipseRecalls & reported problems across all models
St. Jude Medical, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,357
- Deaths reported
- 100
- Injuries reported
- 1,218
- Recalls
- 0
We found 12 models of Ellipse by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 3,357 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 30, 2026 — classified as 100 deaths, 1,218 injuries, 2,039 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (1,113 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Ellipse problems
Device problems
- Over-Sensing1,113
- Adverse Event Without Identified Device or Use Problem544
- Inappropriate or Unexpected Reset510
- Inappropriate/Inadequate Shock/Stimulation402
- Incorrect Interpretation of Signal217
- Under-Sensing185
- Signal Artifact/Noise108
- Failure to Deliver Shock/Stimulation93
Patient problems
- No Clinical Signs, Symptoms or Conditions1,261
- No Known Impact Or Consequence To Patient994
- Unspecified Infection357
- Therapeutic Effects, Unexpected154
- Discomfort123
- No Consequences Or Impact To Patient122
- Arrhythmia119
- Insufficient Information101
Ellipse models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ellipse™ CD2411-36QPulse generator, permanent, implantable42 deaths1,498 reports
- Ellipse™ CD1411-36QPulse generator, permanent, implantable17 deaths694 reports
- Ellipse™ CD2411-36CPulse generator, permanent, implantable17 deaths569 reports
- Ellipse™ CD1411-36CPulse generator, permanent, implantable14 deaths248 reports
- Ellipse™ CD2311-36QPulse generator, permanent, implantable3 deaths124 reports
- Ellipse™ CD1311-36QPulse generator, permanent, implantable4 deaths109 reports
- Ellipse™ DRPulse generator, permanent, implantable1 death79 reports
- Ellipse™ CD1311-36Pulse generator, permanent, implantable2 deaths25 reports
- Ellipse™ CD1275-36QPulse generator, permanent, implantable5 reports
- Ellipse™ CD1275-36Pulse generator, permanent, implantable3 reports
- Ellipse™ CD2275-36QPulse generator, permanent, implantable2 reports
- Ellipse™ CD2275-36Pulse generator, permanent, implantable1 report
Recent Ellipse adverse event reports
The 15 most recent reports across all models, 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 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 ↗MalfunctionSep 8, 2026Signal Artifact/Noise
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677630 ↗MalfunctionAug 26, 2026Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50464926 ↗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 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 ↗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 ↗MalfunctionJul 31, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105053 ↗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 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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