Ellipse™ CD1311-36QRecalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 05414734506113), received between Jun 18, 2018 and Jul 10, 2024 — classified as 4 deaths, 45 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (26 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED NOISE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716724 ↗
• MalfunctionMar 20, 2024Incorrect Measurement; Inappropriate or Unexpected Reset; Incorrect Measurement; Inappropriate or Unexpected Reset

  IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON INTERROGATION, IT WAS DISCOVERED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE. THE ICD WAS SUCCESSFULLY RESTORED. AFTER THE ICD WAS RESTORED FROM BACKUP MODE, THE ICD OVERESTIMATED THE REMAINING BATTERY LIFE DUE TO THE LOSS OF CHARGE HISTORY DATA FROM BEFORE THE BACKUP OCCURRED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941898 ↗
• InjuryNov 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-73107. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFECTION. THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR WAS EXPLANTED. PATIENT STATUS WAS NOT KNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18207845 ↗
• MalfunctionNov 22, 2023Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS. PREMATURE BATTERY DEPLETION, CHARGE TIME OUT.

  Patient problems: Insufficient Information

  MAUDE report 18193720 ↗
• MalfunctionOct 31, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN-CLINIC FOLLOW-UP. A DEVICE INTERROGATION REVEALED EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVER-SENSING RECORDED ON THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR. THE EPISODES WERE A RESULT OF POST-PACED T WAVE OVERSENSING. PROGRAMMING INTERVENTIONS WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044349 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-49897. 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 17950366 ↗
• MalfunctionMar 29, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR IN-CLINIC FOLLOW-UP WITH EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVER-SENSING RECORDED ON THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR. THE EPISODES WERE A RESULT OF POST-PACED T WAVE OVERSENSING. PROGRAMMING INTERVENTIONS WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633774 ↗
• MalfunctionMar 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC DUE TO A POTENTIAL DEVICE ISSUE. FURTHER INFORMATION WAS UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16631789 ↗
• InjuryMar 16, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNRELATED PROCEDURE, AND A MAGNET WAS PLACED OVER THE PATIENT'S ICD WHILE CAUTERY WAS USED HOWEVER, THE PATIENT RECEIVED AN APPROPRIATE SHOCK. DEVICE INTERROGATION WAS PERFORMED, AND IT WAS NOTED THAT THE MAGNET HAD FALLEN/MOVED DURING THE PROCEDURE. THERE WERE NO HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552955 ↗
• InjuryMar 7, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE DEVICE DELIVERED INAPPROPRIATE SHOCK/THERAPY. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499746 ↗
• InjuryFeb 26, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2023 FOR A FOLLOW-UP WITH NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) ALERTS. REVIEW OF THE TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNDER-SENSING CARDIAC EVENTS. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2023. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441330 ↗
• MalfunctionJan 24, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED DURING CLINICAL FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND IN BACKUP MODE DUE TO EVENT QUEUE OVERFLOW. PROGRAMMING CHANGES WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234120 ↗
• MalfunctionJan 23, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT ISSUES WITH TELEMETRY RF AND CONNECTING WITH TRANSMITTER WERE OBSERVED. IT WAS SUGGESTED TO TRY THE CYBERSECURITY UPGRADE OR FIRMWARE UPGRADE TO FIX THE ISSUE. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224088 ↗
• InjuryJan 11, 2023Failure to Charge; Failure to Charge

  NEW INFORMATION NOTES THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATION WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135387 ↗
• MalfunctionJan 3, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-SENSED T-WAVE OVERSENSING (PSTWOS). PROGRAMMING CHANGES WERE IMPLEMENTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092290 ↗
• MalfunctionDec 28, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN BACKUP VVI MODE DUE TO AN UNSPECIFIED REASON. PREVIOUS DEVICE SETTINGS WERE RESTORED AND THE ISSUE WAS RESOLVED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064709 ↗
• DeathNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-47193. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2022. 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 CONGESTIVE HEART FAILURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 15888074 ↗
• InjuryAug 12, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND TO BE IN BACKUP OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222193 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS SUCCESSFULLY REPLACED. FURTHER INFORMATION WAS REQUESTED, BUT NOT YET AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15187117 ↗
• DeathAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DECEASED DUE TO AN UNKNOWN CAUSE. NO ADDITIONAL INFORMATION WAS REPORTED. INFECTION WAS ALSO NOTED.

  Patient problems: Unspecified Infection

  MAUDE report 15139527 ↗
• MalfunctionJun 21, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR A FOLLOW UP IN CLINIC WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT WAS IN BACKUP OPERATION. PROGRAMMING CHANGES WERE MADE TO RESTORE NORMAL DEVICE FUNCTION. THE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14761954 ↗
• DeathJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER:2017865-2022-12101. IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643637 ↗
• MalfunctionJun 3, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, IT WAS FOUND THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BACKUP MODE. THE DEVICE 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 14598419 ↗
• MalfunctionMay 9, 2022Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACKUP MODE. NO CHANGES OR INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14341611 ↗
• InjuryApr 18, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A FOLLOW-UP ON (B)(6). UPON INTERROGATION, IT WAS NOTED THAT THERE WAS A MAXIMUM CHARGE TIME ALERT FROM (B)(6) ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN EXPLANTED AND REPLACED THE ICD ON (B)(6) 2022. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139293 ↗