Fortify Assura™ CD2357-40CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,378 adverse event reports that list this exact device (DI 05414734508063), received between Jun 11, 2018 and Sep 16, 2026 — classified as 25 deaths, 658 injuries, 695 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (444 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,378 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing

  It was reported that the device delivered an inappropriate therapy due to incorrect interpretation of signal caused by intermittent atrial undersensing. No intervention was performed, and no patient symptoms were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790187 ↗
• DeathSep 10, 2026Failure to Convert Rhythm; Low impedance

  It was reported that the right ventricular (RV) lead's high voltage (HV) impedance was observed to be low via remote monitoring. The patient was noted to be in ventricular fibrillation (VF) and the Implantable Cardioverter Defibrillator (ICD) attempted to shock. On the third attempt the patient did convert successfully in the right ventricular (RV) to Superior Vena Cava (SVC) shocking vector. The patient was in and out of VF since 1:00 PM that day and the observation was made at 11:50 PM. A transmission at 2:00 AM noted a normal rhythm. The clinician contacted the patient, and it was noted that the patient had passed away in the middle of the night.

  Patient problems: Arrhythmia

  MAUDE report 50704857 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the hospital with pain at the device pocket. It was also noted that the patient's implantable cardioverter defibrillator (ICD) had eroded through the skin. The ICD was explanted. A new ICD system was implanted. The patient had no adverse consequences.

  Patient problems: Discomfort; Pocket Erosion

  MAUDE report 50703807 ↗
• MalfunctionSep 8, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50680134 ↗
• InjurySep 4, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient presented to the emergency room after the Implantable Cardioverter Defibrillator (ICD) delivered inappropriate shocks which the patient felt. The shocks were determined to be caused by oversensing noise on the ICD, stored as Non-Sustained Right Ventricular Oversensing (NSRVO) episodes. Therapy was disabled, and the ICD was explanted and replaced with a new device. The patient's condition remained stable.

  Patient problems: Discomfort

  MAUDE report 50619605 ↗
• MalfunctionSep 1, 2026Over-Sensing; Pacing Problem

  It was reported that a patient presented remotely via Merlin.net. Review of the transmission revealed that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited far-field R-wave oversensing resulted in an inappropriate Automatic Mode Switch (AMS) episode. Programming changes were discussed, no changes or interventions were reported. The patient condition was not known.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50545261 ↗
• MalfunctionAug 26, 2026Pacing Asynchronously; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50465083 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient presented to clinic with an adverse event of infection. A causal relationship between the reported infection and the procedure or the Abbott device could not be determined. The implantable cardioverter defibrillator (ICD) and right atrial (RA) lead were explanted. The patient was stable throughout the procedure. The cause of the infection was unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50189912 ↗
• MalfunctionJul 7, 2026Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSING DUE TO CROSSTALK. NO INTERVENTION WAS REPORTED. PATIENT CONDITION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25728616 ↗
• InjuryJun 29, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MISINTERPRETED SUPRAVENTRICULAR TACHYCARDIA (SVT), WITH VENTRICULAR RATES FALLING WITHIN THE VENTRICULAR TACHYCARDIA (VT) ZONE, AND DELIVERED AN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). PROGRAMMING CHANGES WERE DONE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25658196 ↗
• MalfunctionJun 29, 2026Failure to Deliver Shock/Stimulation; Incorrect Interpretation of Signal

  IT WAS REPORTED THAT VENTRICULAR TACHYCARDIA (VT) EPISODES WERE MISDIAGNOSED AS SUPRAVENTRICULAR TACHYCARDIA (SVT) RESULTING IN NO ANTI TACHYCARDIA RESPONSE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS JUST BEING MONITORED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25651621 ↗
• MalfunctionJun 8, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INTERMITTENT ATRIAL UNDER SENSING. PROGRAMMING CHANGES WERE DISCUSSED, NO CHANGES OR INTERVENTIONS WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435237 ↗
• MalfunctionJun 4, 2026Over-Sensing

  IT WAS REPORTED THAT POST PACED T WAVE OVERSENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).

  Patient problems: Insufficient Information

  MAUDE report 25402876 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ICD DETECTED ONE EPISODE OF VENTRICULAR FIBRILLATION (VF) THAT APPEARED TO BE POLYMORPHIC VENTRICULAR TACHYCARDIA (PMVT). THE DEVICE INITIALLY ATTEMPTED ANTITACHYCARDIA PACING (ATP), WHICH WAS UNSUCCESSFUL. IT THEN DELIVERED A 36-JOULE SHOCK, WHICH SUCCESSFULLY CONVERTED THE RHYTHM TO ATRIAL FIBRILLATION WITH VENTRICULAR SENSING (AFVS) AND VENTRICULAR PACING (VP) AT A CONTROLLED RATE. AT THE TIME OF THE EVENT, THE PATIENT WAS FOUND UNRESPONSIVE FOR APPROXIMATELY 30 SECONDS. UPON WAKING, THE PATIENT DENIED ANY IMMEDIATE SYMPTOMS. NORMAL DEVICE FUNCTION WAS NOTED. THE DEVICE WAS LATER ELECTIVELY EXPLANTED AND REPLACED. NO PATIENT CONDITION WAS REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 25218835 ↗
• MalfunctionMay 18, 2026Over-Sensing

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT FAR P WAVE OVERSENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211348 ↗
• MalfunctionApr 22, 2026Over-Sensing; Pacing Problem

  NEW INFORMATION RECEIVED NOTED THAT THE PATIENT CONDITION WAS STABLE BEFORE, DURING, AND AFTER THE CHANGES.

  Patient problems: Dizziness; Dyspnea

  MAUDE report 24960779 ↗
• MalfunctionApr 22, 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 DISCUSSED BUT NO INTERVENTION WAS PERFORMED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960632 ↗
• MalfunctionApr 22, 2026Over-Sensing

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT NON SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) DETERMINED TO BE CROSSTALK WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE COMPLETED. THE PATIENT WAS BEING MONITORED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955568 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH FEVER, INFECTION AND ENDOCARDITIS AT DEVICE POCKET. THE DEVICE IS NOT A SOURCE OF INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 24948406 ↗
• MalfunctionApr 16, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THE PATIENT PRESENTED FOR FOLLOW-UP IN CLINIC AFTER A MAGNETIC RESONANCE IMAGING (MRI). UPON INTERROGATION, IT WAS DISCOVERED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IN BACK UP MODE WITH NO BACK-UP DEFIBRILLATION OPTION (BDFO) AVAILABLE DUE TO OFF-LABEL USE WITH THE MRI. THE ICD WAS SUCCESSFULLY RESTORED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901504 ↗
• MalfunctionApr 15, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT DURING REMOTE FOLLOW-UP, THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FAR-FIELD R-WAVE OVERSENSING THAT CAUSED INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS). PROGRAMMING CHANGES WERE DISCUSSED, NO CHANGES OR INTERVENTIONS WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889645 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC DUE TO POCKET EROSION. THE PACEMAKER WAS EXPLANTED TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Pocket Erosion

  MAUDE report 24842687 ↗
• MalfunctionApr 3, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR FOLLOW-UP. REVIEW OF THE ELECTROGRAM (EGM) REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ATRIAL AND VENTRICULAR OVERSENSING NOISE. PROGRAMMING CHANGES WERE PERFORMED, AND THE OVERSENSING NOISE WAS RESOLVED. AFTER THE PROGRAMMING CHANGES, ATRIAL UNDER-SENSING WAS NOTED ON THE ICD, WITH THE ATRIAL CHANNEL CURRENTLY PROGRAMMED TO THE LEAST SENSITIVE SETTING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24782686 ↗
• MalfunctionApr 3, 2026Inappropriate or Unexpected Reset

  IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD GONE INTO BACKUP MODE. HIGH VOLTAGE THERAPIES WERE STILL AVAILABLE. CAUSE OF THE RESET AND PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781526 ↗
• InjuryMar 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED A PERFORMANCE ISSUE. THE DEVICE WAS EXPLANTED. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24683886 ↗