EntrantRecalls & reported problems across all models

We found 8 models of Entrant by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 658 adverse event reports in the FDA's MAUDE database, received between Dec 3, 2020 and Sep 30, 2026 — classified as 7 deaths, 112 injuries, 539 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (287 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Entrant recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-2615-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

2. 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 · names 2 of these models · Recall details · FDA record ↗

Most reported Entrant problems

Entrant models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Entrant™ CDHFA300Q

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall3 deaths341 reports
• Entrant™ CDDRA300Q

  Pacemaker/icd/crt non-implanted components
  1 recall2 deaths158 reports
• Entrant™ CDVRA300Q

  Implantable cardioverter defibrillator (non-CRT)
  1 recall1 death140 reports
• Entrant™ CDHFA300D

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  8 reports
• Entrant™ CDHFA300T

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death4 reports
• Entrant™ CDVRA300T

  Implantable cardioverter defibrillator (non-CRT)
  3 reports
• Entrant™ CDDRA300T

  Implantable cardioverter defibrillator (non-CRT)
  2 reports
• Entrant™ CDHFA300B

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 reports

Recent Entrant adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953717 ↗
• MalfunctionSep 30, 2026Signal Artifact/Noise; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953114 ↗
• MalfunctionSep 30, 2026Over-Sensing

  It was reported that episodes of post-paced T-wave oversensing (PPTWOS) 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950810 ↗
• MalfunctionSep 28, 2026Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926697 ↗
• MalfunctionSep 28, 2026Failure to Interrogate; Inappropriate or Unexpected Reset

  It was reported that three weeks post-implantation, the patient reported hearing an audible alert tone from the device. During a follow-up clinic visit, the physician found that the device had entered backup VVI mode with no backup defibrillation function on (BDFO). There were unsuccessful attempts to interrogate the device. Following troubleshooting, it was decided to replace the generator with a new device. The patient was in stable condition with no adverse events.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915146 ↗
• MalfunctionSep 26, 2026Over-Sensing

  Patient problems: Insufficient Information

  MAUDE report 50906592 ↗
• MalfunctionSep 24, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890131 ↗
• 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 16, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794024 ↗
• MalfunctionSep 16, 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 50789937 ↗
• MalfunctionSep 11, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740881 ↗
• MalfunctionSep 10, 2026Capturing Problem

  It was reported that varying capture thresholds were observed on the Implantable Cardioverter Defibrillator (ICD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718950 ↗
• MalfunctionSep 9, 2026Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50702913 ↗
• MalfunctionSep 9, 2026Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699363 ↗

Other St. Jude Medical, Inc. products

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