Entrant™ CDDRA300QRecalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 05415067032843), received between Dec 3, 2020 and Sep 30, 2026 — classified as 2 deaths, 35 injuries, 121 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (44 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 16, 2023Open, Classified

   Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.

   Z-2614-2023 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 158 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Signal Artifact/Noise; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953114 ↗
• MalfunctionSep 28, 2026Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926697 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was implanted with implantable cardioverter defibrillator (ICD) on (b)(6) 2026. Post-operatively, the patient experienced recurrent fever. Subsequent echocardiography and ultrasound revealed vegetation on the atrial lead. A causal relationship between the reported infection and the procedure or the Abbott device could not be determined. Despite prolonged antibiotic therapy, the patient's condition did not improve. As a result, the ICD, atrial lead and right ventricle (RV) lead were explanted on (b)(6) 2026. Blood culture was taken however, the result was not reported. The patient had no consequences throughout the procedure. The cause of infection was related to vegetation on atrial lead.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 50877038 ↗
• MalfunctionSep 18, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828931 ↗
• MalfunctionSep 11, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740881 ↗
• MalfunctionSep 9, 2026Incorrect Measurement

  It was reported that during follow-up in-clinic, the patient's Implantable Cardioverter Defibrillator (ICD) exhibited diagnostic discrepancy. No changes or interventions were reported. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50694633 ↗
• MalfunctionSep 9, 2026High impedance; Capturing Problem; Connection Problem

  During a routine device exchange, increased impedance and increased capture thresholds were noted on the device. Inadequate insertion of the leads into the header of the device was suspected. The device was not implanted and a new device was successfully implanted to resolve this event. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690739 ↗
• MalfunctionSep 8, 2026Premature Discharge of Battery; Failure to Deliver Shock/Stimulation

  Patient problems: Arrhythmia

  MAUDE report 50676280 ↗
• MalfunctionSep 4, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50621383 ↗
• MalfunctionAug 25, 2026Over-Sensing; Pacing Asynchronously

  During a remote follow-up, episodes of post-paced T-wave oversensing (PPTWO) and fusion were observed on the device. Technical Support was contacted and recommended reprogramming to resolve the event. No intervention has been performed at this time. The patient was stable and will continue to be monitored.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50434747 ↗
• MalfunctionAug 20, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358086 ↗
• MalfunctionJul 29, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  Additional information received indicated that during in clinic follow up, the patient's Implantable Cardioverter Defibrillator (ICD) had gone into backup mode due to a Magnetic Resonance Imaging (MRI) scan where device settings were not enabled prior to the scan. The device was successfully reprogrammed. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50077338 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the system was explanted due to infection. No further information was available.

  Patient problems: Unspecified Infection

  MAUDE report 50011954 ↗
• MalfunctionJun 18, 2026Over-Sensing

  IT WAS REPORTED THAT MYOPOTENTIAL OVERSENSING WAS OBSERVED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING, WHICH WAS ANTICIPATED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553266 ↗
• MalfunctionJun 11, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  FOLLOWING A MAGNETIC RESONANCE IMAGING (MRI), THE DEVICE AS FOUND TO BE IN BACKUP VVI MODE (BVVI) RESULTING IN HIGH-VOLTAGE (HV) THERAPY BEING DISABLED. IT WAS NOTED THAT THE DEVICE WAS NOT PROGRAMMED TO BE IN MRI SETTINGS BEFORE THE MRI SCAN. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481062 ↗
• MalfunctionMay 26, 2026Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH BACK-UP VVI MODE SUE TO HARDWARE RESET WITH LOSS OF BAC-UP DEFIBRILLATION NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO INFORMATION REGARDING INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25273739 ↗
• MalfunctionMay 22, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN CLINIC FOLLOW-UP. ON (B)(6) 2026, AND MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS PERFORMED AFTER THE PATIENT EXPERIENCED A STROKE; HOWEVER, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT MRI-COMPATIBLE. DEVICE INTERROGATION LATER REVEALED THAT THE ICD WAS IN BACKUP MODE WITH HIGH VOLTAGE (HV) THERAPIES DISABLED. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 25260490 ↗
• MalfunctionMay 20, 2026Over-Sensing

  ADDITIONAL INFORMATION WAS RECEIVED THAT PROVOCATIVE TESTING WAS PERFORMED, BUT THE NOISE WAS UNABLE TO BE REPRODUCED. NO FURTHER INTERVENTION HAS BEEN PERFORMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234080 ↗
• MalfunctionMay 19, 2026Over-Sensing

  IT WAS REPORTED THAT DURING A REMOTE FOLLOW UP, POST-PACED T-WAVE OVERSENSING (PPTWOS) WAS NOTED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND REPROGRAMMING WAS RECOMMENDED. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222153 ↗
• MalfunctionApr 28, 2026Over-Sensing

  DURING AN IN-CLINIC FOLLOW-UP, CROSSTALK OVERSENSING EPISODES WERE OBSERVED ON THE DEVICE RESULTING IN VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) EPISODES. THE VT AND VF WERE SUCCESSFULLY TERMINATED BY THE DEVICE. THE DEVICE WAS THEN REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT IS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 25019379 ↗
• MalfunctionApr 23, 2026Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR INITIAL IMPLANT. AFTER THE PROCEDURE, THE DEVICE WAS INTERROGATED, AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED BACKUP MODE WITH HIGH VOLTAGE (HV) THERAPIES DISABLED. THE PHYSICIAN SUSPECTED THE CAUSE TO BE RELATED TO DEVICE TRANSPORT. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968142 ↗
• MalfunctionApr 10, 2026Over-Sensing

  DURING A REMOTE FOLLOW-UP, EPISODES OF POST PACED T-WAVE OVERSENSING (PPTWOS) WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING TO RESOLVE THE EVENT. REPROGRAMMING WAS PERFORMED TO RESOLVE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844284 ↗
• MalfunctionApr 3, 2026High impedance; Loose or Intermittent Connection

  DURING A DEVICE REPLACEMENT PROCEDURE, AN INCREASE IN PACING IMPEDANCE WAS OBSERVED ON THE DEVICE. WHEN ATTEMPTING TO CONNECT A RIGHT VENTRICULAR (RV) LEAD INTO THE DEVICE HEADER, THE SETSCREW BECAME STRIPPED. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED TO RESOLVE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772912 ↗
• MalfunctionMar 30, 2026Failure to Capture; High impedance; Failure to Sense; Data Problem

  DURING INITIAL IMPLANT PROCEDURE, LOSS OF CAPTURE (LOC), INCREASED PACING IMPEDANCE, FAILURE TO SENSE, AND ERROR MESSAGE WAS OBSERVED ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709454 ↗
• DeathMar 24, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH BACK-UP VVI MODE NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FOLLOWING MAGNETIC RESONANCE IMAGING (MRI) IN AN OFF-LABEL ENVIRONMENT, AS THE DEVICE WAS NOT SWITCHED INTO MRI MODE. REPROGRAMMING WAS NOT SUCCESSFUL SO A GENERATOR CHANGE WAS PLANNED. IT WAS THEN REPORTED THE PATIENT DECEASED DUE TO UNDERLYING MEDICAL COMPLICATIONS. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678153 ↗