Ellipse™ CD1275-36QRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734506038), received between Jul 16, 2018 and Jul 22, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2021Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  DURING AN IN-CLINIC FOLLOW-UP, THE DEVICE WAS FOUND IN BACKUP MODE DUE TO OFF-LABEL MRI USE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND ASSISTED IN REPROGRAMMING THE DEVICE TO SUCCESSFULLY RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210362 ↗
• MalfunctionNov 3, 2020Low impedance; Low impedance

  A REMOTE TRANSMISSION WAS RECEIVED INDICATING LOW PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE PATIENT WAS THEN SEEN IN-CLINIC AND PROVOCATIVE TESTING AND FLUOROSCOPIC IMAGING WAS CONDUCTED WHICH WERE BOTH UNREMARKABLE. NO INTERVENTION HAS BEEN CONDUCTED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10782036 ↗
• InjuryJun 12, 2019Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF). THERAPY WAS DELIVERED BUT WAS NOT SUCCESSFUL IN TERMINATING THE VF. THE PATIENT RECEIVED EXTERNAL DEFIBRILLATION WHICH FINALLY TERMINATED THE ARRHYTHMIA. DUE TO THE LENGTH OF THE EPISODE, THE PATIENT SUFFERED CEREBRAL CONSEQUENCES DUE TO HYPOXIA. THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU) AND IS ON A RESPIRATOR. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED.

  Patient problems: Hypoxia; Neurological Deficit/Dysfunction

  MAUDE report 8693441 ↗
• MalfunctionSep 14, 2018Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  PRIOR TO PROCEDURE, IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE IN BACK UP MODE (BVVI). THE DEVICE WAS NEVER USED AND NO PATIENT WAS INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7878620 ↗
• MalfunctionJul 16, 2018Fitting Problem; Fitting Problem

  RELATED TO MANUFACTURER REPORT NUMBER: 2938836-2018-08519. DURING FOLLOW-UP, INCREASED HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. A NEW RV LEAD WAS IMPLANTED TO TRY AND RESOLVE THE ISSUE BUT THE IMPEDANCE REMAINED HIGH. THE ISSUE WAS RESOLVED BY EXPLANTING AND REPLACING THE DEVICE. THE OLD LEAD WAS CONNECTED AND THE NEW LEAD WAS ELECTIVELY EXPLANTED. THE PATIENT WAS IN STABLE CONDITION AND EXPERIENCED NO ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7690019 ↗