Ellipse™ DRRecalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 05414734505987), received between Jun 13, 2018 and Mar 1, 2024 — classified as 1 death, 29 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (29 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2024Signal Artifact/Noise; Failure to Capture; Signal Artifact/Noise; Failure to Capture

  IT WAS REPORTED, THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON INTERROGATION, IT WAS NOTED, THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING FAILURE TO CAPTURE. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2024. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822821 ↗
• MalfunctionSep 28, 2023Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 17831143 ↗
• MalfunctionNov 4, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED THE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED ERI. IT WAS NOTED, THAT A PREVIOUS BATTERY LONGEVITY HAD BEEN OVERESTIMATED. THE ICD WAS EXPLANTED AND REPLACED DUE TO ERI. THE PATIENT CONDITION WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15739793 ↗
• MalfunctionAug 25, 2022Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 15296039 ↗
• MalfunctionJul 28, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC. UPON INTERROGATION, THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND TO HAVE MYOPOTENTIALS OVER-SENSING, WHICH RESULTED IN NON-SUSTAINED V OVERSENSING EPISODES. CORRECTIVE PROGRAMMING CHANGES WERE MADE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122932 ↗
• MalfunctionApr 22, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED MYOPOTENTIAL OVERSENSING. AFTER CONSIDERATION, IT WAS NOTED THAT IT WAS DUE TO A COUGHING SPELL AND IT ONLY HAPPENED WHEN THE PATIENT HAD COVID. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190087 ↗
• MalfunctionJan 25, 2022Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 13349134 ↗
• MalfunctionNov 17, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS POST-PACED T-WAVE OVER-SENSING (PPTWOS). THE PATIENT WAS ASYMPTOMATIC. THE ICD WAS REPROGRAMMED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829823 ↗
• MalfunctionNov 12, 2021Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12805661 ↗
• InjuryOct 28, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  NEW INFORMATION RECEIVED NOTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. THE PATIENT WAS ASYMPTOMATIC BEFORE, DURING AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12716185 ↗
• InjuryOct 5, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE OUT PROCEDURE. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND TO BE IN THE BACK-UP MODE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS EXPLANTED AND REPLACED. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577930 ↗
• InjuryJun 21, 2021Over-Sensing; Defective Device; Over-Sensing; Defective Device

  IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED FAR FIELD OVERSENSING AND NOISE THAT WAS OVERSENSED BY THE DEVICE. BOTH SENSING ANOMALIES WERE UNABLE TO BE REPRODUCED IN CLINIC. THE PHYSICIAN ALLEGED THE SOURCE OF THE NOISE WAS AN ISSUE INSIDE THE HEADER. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037465 ↗
• MalfunctionJun 1, 2021Over-Sensing; Over-Sensing

  NEW INFORMATION NOTES THAT THE PROGRAMMING CHANGES WERE MADE ON THE DEVICE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917925 ↗
• MalfunctionMay 21, 2021Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR A FOLLOW UP IN CLINIC. IT WAS NOTED THAT THERE WAS NO RADIOFREQUENCY (RF) TELEMETRY ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. A FIRMWARE UPGRADE WAS COMPLETED SUCCESSFULLY AND TELEMETRY WAS RESTORED. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE UPGRADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863923 ↗
• MalfunctionMay 12, 2021Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  NEW INFORMATION RECEIVED NOTES THAT CORRECTIVE PROGRAMMING CHANGES WERE PERFORMED ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813222 ↗
• MalfunctionApr 27, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY ON (B)(6) 2021 WITH EPISODES OF POST-PACED T-WAVE OVERSENSING ON THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. PROGRAMMING CHANGES WERE MADE (B)(6) 2021. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730235 ↗
• MalfunctionApr 21, 2021Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN HOSPITAL FOR A SCHEDULED GENERATOR CHANGE. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO REMOVE THE RIGHT VENTRICULAR (RV) LEAD PIN FOR THE RV PORT AFTER SUCCESSFULLY ENGAGING AND LOOSENING THE SET SCREW. THE PHYSICIAN PROCEEDED TO REMOVE THE SILICONE SEPTUM AND SET SCREW FROM THE DEVICE HEADER USING MOSQUITO FORCEPS BUT REMAINED UNABLE TO REMOVE THE RV LEAD PIN FROM THE RV PORT. THE PHYSICIAN ATTEMPTED TO APPLY LEVERAGE TO THE LEAD PIN THROUGH THE SET SCREW CHANNEL USING VARIOUS INSTRUMENTS (TIP SCALPEL, TIP MOSQUITO FORCEPS, LONG END OF AN "L" SHAPED WRENCH), WITHOUT SUCCESS. ORTHPEDIC BONE NIPPERS WERE SUBSEQUENTLY USED TO CUT THROUGH THE HEADER TO FREE THE LEAD, WITH SUCCESS. THE RV LEAD WAS TESTED FOLLOWING IT'S REMOVAL, WITH PACING SYSTEM ANALYZER MEASUREMENTS STABLE WHEN COMPARED TO TESTING PERFORMED IN HOLDING PRIOR TO CASE START. THE CASE PROCEEDED AND CONCLUDED WITHOUT FURTHER COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700955 ↗
• InjuryFeb 3, 2021Failure to Charge; Failure to Charge

  IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC. THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED CHARGE TIME LIMIT. THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276953 ↗
• MalfunctionDec 1, 2020Failure to Disconnect; Failure to Disconnect

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-19435. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A GENERATOR CHANGE PROCEDURE. DURING THE PROCEDURE, THE RIGHT VENTRICULAR LEAD WAS STUCK IN THE HEADER OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DESPITE THE SET SCREW BEING LOOSENED. THE LEAD WAS REMOVED USING A BONE CUTTER. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL LEAD HAD EXTERNALIZED CONDUCTORS DUE TO PROCEDURAL DAMAGE. THE RIGHT ATRIAL LEAD WAS CAPPED AND NOT REPLACED DURING PROCEDURE ON (B)(6) 2020 DUE TO THE PATIENT EXPERIENCING CHRONIC ATRIAL FIBRILLATION. THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10928783 ↗
• InjuryNov 29, 2020Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED FAR-FIELD P-WAVE OVERSENSING RESULTING IN INAPPROPRIATE SHOCK. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10916652 ↗
• InjuryNov 10, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED INAPPROPRIATE ANTI-TACHYCARDIA PACING DUE TO P WAVES FALLING INTO BLANKING AND CAUSING THE DEVICE TO IDENTIFY VENTRICLE RATE BRANCH MORE THAN THE ATRIAL RATE BRANCH. NO INTERVENTION WAS PERFORMED. NO PATIENT CONSEQUENCES.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10820498 ↗
• MalfunctionOct 8, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE ICD EXHIBITED POST SENSED T WAVE OVERSENSING. PROGRAMMING CHANGES WERE SUGGESTED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10653556 ↗
• InjurySep 9, 2020Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM HAVING RECEIVED SHOCK THERAPY. UPON INTERROGATION, IT WAS OBSERVED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS INCORRECTLY INTERPRETING TACHYCARDIA EPISODES AND INAPPROPRIATELY DELIVERING SHOCK. PROGRAMMING CHANGES WERE COMPLETED TO ADDRESS THIS ISSUE. THE PATIENT WAS STABLE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10508417 ↗
• InjuryAug 25, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM. UPON REVIEW, IT WAS REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR PROVIDED AN INAPPROPRIATE SHOCK. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10446863 ↗
• MalfunctionAug 22, 2020Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THAT REACHED CAPACITOR CHARGE TIME. NO FURTHER INTERVENTION WAS MADE AT THE TIME. PATIENT WOULD BE FURTHER MONITORED. PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10440534 ↗