Entrant™ CDVRA300QRecalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 05415067032836), received between May 19, 2021 and Sep 24, 2026 — classified as 1 death, 40 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (47 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 140 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890131 ↗
• MalfunctionSep 9, 2026Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699363 ↗
• MalfunctionSep 9, 2026Loose or Intermittent Connection; Connection Problem

  It was reported that the patient presented for an Implantable Cardioverter Defibrillator (ICD) implant procedure. Upon implant, it was noted that the header was not able to secure the lead because the set screw would not tighten. The ICD was not implanted on 22 Aug 2026 and successfully replaced. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696032 ↗
• DeathAug 27, 2026Failure to Deliver Shock/Stimulation; Inappropriate or Unexpected Reset

  It was reported that the patient presented for initial Implantable Cardioverter Defibrillator (ICD) and Right Ventricular (RV) lead implant on (b)(6) 2026. The following day, the patient's ICD inappropriately went into backup operation with high voltage therapies disabled. It was suspected that the cause of backup operation was the ICD delivering too many appropriate shocks to the patient. The patient was found deceased after being discharged from the hospital on (b)(6) 2026. The cause of death was suspected to be either progression of underlying heart failure or the patient being in slow Ventricular Tachycardia (VT) that went untreated by the ICD.

  Patient problems: Arrhythmia; Heart Failure/Congestive Heart Failure

  MAUDE report 50479157 ↗
• MalfunctionAug 17, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  Following a magnetic resonance imaging (MRI), the device was 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 with no consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50276183 ↗
• MalfunctionAug 12, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  Following a magnetic resonance imaging (MRI), the device was found to be in backup VVI mode (BVVI) resulting in high-voltage (HV) therapy being disabled. The device had not been programmed into MRI mode. Technical Support was contacted, and the device was reprogrammed to resolve the event. The patient was stable with no consequences

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223761 ↗
• InjuryJul 30, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the device delivered high voltage therapy during episodes of a non-ventricular arrhythmia. 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 50085153 ↗
• MalfunctionJun 28, 2026Inappropriate or Unexpected Reset; Compatibility Problem

  FOLLOWING A MAGNETIC RESONANCE IMAGING (MRI), THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE (BVVI) RESULTING IN HIGH-VOLTAGE (HV) THERAPY BEING DISABLED. TECHNICAL SUPPORT WAS CONTACTED, AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25647900 ↗
• MalfunctionJun 17, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  FOLLOWING A MAGNETIC RESONANCE IMAGING (MRI), THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE (BVVI) RESULTING IN HIGH-VOLTAGE (HV) THERAPY BEING DISABLED. THE DEVICE HAD NOT BEEN PROGRAMMED INTO MRI MODE. TECHNICAL SUPPORT WAS CONTACTED, AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25532596 ↗
• InjuryJun 8, 2026Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, THE DEVICE WAS FOUND TO BE IN BACKUP VVI (BVVI) MODE RESULTING IN DISABLED HIGH VOLTAGE THERAPY. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, HOWEVER, THE DEVICE WAS UNABLE TO BE SUCCESSFULLY REPROGRAMMED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428533 ↗
• MalfunctionJun 5, 2026Inappropriate or Unexpected Reset; Compatibility Problem

  FOLLOWING A MAGNETIC RESONANCE IMAGING (MRI), THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE (BVVI). TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS RESTORED AND REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT IS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410908 ↗
• InjuryJun 5, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) DELIVERED BY THE DEVICE DUE TO SINUS TACHYCARDIA. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409075 ↗
• InjuryJun 3, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE DEVICE INAPPROPRIATE DELIVERED HIGH VOLTAGE THERAPY FOR ATRIAL FIBRILLATION. THE PHYSICIAN ALLEGED THE DEVICE PERFORMED AS EXPECTED BASED ON THE PROGRAMMED SETTINGS. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385744 ↗
• MalfunctionMay 17, 2026Inappropriate or Unexpected Reset; Compatibility Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH BACK-UP VVI MODE NOTED DUE TO USE IN A MAGNETIC RESONANCE IMAGING ENVIRONMENT. THE DEVICE WAS RESTORED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196903 ↗
• MalfunctionMay 5, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE DEVICE WAS IN BACKUP MODE WITH NO HIGH VOLTAGE DEFIBRILLATION THERAPY AVAILABLE FOLLOWING A MAGNETIC RESONANCE IMAGING (MRI) SCAN. THE CAUSE WAS DUE TO THE DEVICE NOT BEING REPROGRAMMED TO MRI MODE PRIOR TO THE SCAN. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085581 ↗
• MalfunctionApr 29, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  FOLLOWING A MAGNETIC RESONANCE IMAGING (MRI), THE DEVICE AS FOUND TO BE IN BACKUP VVI MODE (BVVI). THE DEVICE HAS NOT BEEN PROGRAMMED INTO MRI MODE. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037787 ↗
• MalfunctionApr 21, 2026Loose or Intermittent Connection

  DURING A ROUTINE DEVICE EXCHANGE, IT WAS NOTED TO BE DIFFICULT TO SCREW THE SETSCREW INTO THE HEADER OF THE DEVICE. ALTERNATIVE MANEUVERING OF THE SETSCREW WAS PERFORMED AND THE DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938169 ↗
• MalfunctionApr 11, 2026Failure to Interrogate

  DURING A FOLLOW-UP, THERE WAS A LOSS OF PAIRING BETWEEN THE DEVICE AND MOBILE APPLICATION, AFTER TROUBLESHOOTING THE DEVICE WAS STILL UNABLE TO PAIR USING BLUETOOTH (BLE) TELEMETRY. NO KNOWN INTERVENTION HAS BEEN PERFORMED, HOWEVER THE DEVICE IS NOW COMMUNICATING VIA BLE. THE PATIENT IS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847974 ↗
• MalfunctionApr 10, 2026Over-Sensing

  IT WAS REPORTED THAT NOISE RESULTING IN OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. ADDITIONALLY, MYOPOTENTIAL OVERSENSING WAS OBSERVED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT RECOMMENDED REPROGRAMMING TO RESOLVE THE EVENT, HOWEVER, NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845277 ↗
• MalfunctionApr 10, 2026Connection Problem; Impedance Problem

  DURING IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS DIFFICULT TO BE INSERTED IN THE RV PORT OF THE HEADER OF THE DEVICE. THE RV LEAD WAS ATTACHED BUT THE IMPEDANCE WAS NOT DETECTABLE. THE RV LEAD WAS REMOVED AND ATTEMPTED TO BE REATTACHED TO THE HEADER OF THE DEVICE, BUT THIS WAS NOT SUCCESSFUL. 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 24844074 ↗
• InjuryMar 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS SUSPECTED ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24548228 ↗
• MalfunctionFeb 24, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ENTERED BACKUP VVI OPERATION FOLLOWING AN MRI SCAN. BACKUP DEFIBRILLATION OPERATION WAS NOT AVAILABLE. PROGRAMMING CHANGES WERE MADE TO RESTORE NORMAL OPERATION. PATIENT WAS STABLE THROUGHOUT THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434459 ↗
• InjuryFeb 20, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT OVERSENSING OF ELECTROMAGNETIC INTERFERENCE (EMI) RESULTING IN INAPPROPRIATE ANTITACHYCARDIA PACING WAS OBSERVED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402139 ↗
• MalfunctionFeb 10, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED, FOLLOWING AN MRI, THE DEVICE WAS OBSERVED TO BE IN BACK UP MODE. TECHNICAL SUPPORT WAS CONTACTED AND IT WAS NOTED THE DEVICE HAD NOT BEEN PROGRAMMED INTO MRI MODE PROPERLY. TECHNICAL SUPPORT PERFORMED REPROGRAMMING TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309168 ↗
• MalfunctionFeb 2, 2026Failure to Interrogate; Incorrect Measurement; No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED A MEASUREMENT ERROR WITH BLUETOOTH TELEMETRY LOSS. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242488 ↗