Entrant™ CDHFA300QRecalls & reported problems
St. Jude Medical, Inc. · HF Cardiac Resychronisation Therapy Defibrillator VVED DDDRV · Class 3 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This St. Jude Medical Entrant heart defibrillator is an implanted device that also paces the heart. Its 336 reports mostly describe the device reading heartbeats incorrectly, unexpected resets and loose connections. The reports mention 3 deaths and 35 injuries. One recall is open, begun in August 2023, over a Bluetooth malfunction in some older units that was traced to a crystal component.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 341
- Deaths reported
- 3
- Injuries reported
- 34
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 341 adverse event reports that list this exact device (DI 05415067032850), received between Dec 9, 2020 and Sep 30, 2026 — classified as 3 deaths, 34 injuries, 304 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (220 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.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Over-Sensing220
- Loose or Intermittent Connection21
- Inappropriate or Unexpected Reset19
- Pacing Asynchronously17
- Failure to Interrogate16
- Inappropriate/Inadequate Shock/Stimulation13
- Environmental Compatibility Problem12
- Adverse Event Without Identified Device or Use Problem11
Patient problems
- No Clinical Signs, Symptoms or Conditions318
- Insufficient Information8
- Unspecified Infection7
- Arrhythmia6
- Discomfort4
- Pocket Erosion3
- Hematoma2
- Wound Dehiscence2
Recent adverse event reports
The 25 most recent of 341 reports, 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, 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, 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 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 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 6, 2026Environmental Compatibility Problem; Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50636764 ↗MalfunctionSep 4, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50619375 ↗MalfunctionAug 21, 2026Over-Sensing; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379350 ↗MalfunctionAug 20, 2026Inappropriate or Unexpected Reset; Compatibility Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355754 ↗MalfunctionAug 18, 2026Over-Sensing; Pacing Asynchronously
Additional information was received indicating the Post-Paced T-wave Oversensing (PPTWOS) noted was due to fusion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50306094 ↗InjuryAug 14, 2026Break; Inappropriate or Unexpected Reset; Noise, Audible
It was reported that a patient presented with back-up VVI mode notes on the patient's implantable cardioverter defibrillator due to electromagnetic interference, resulting in a persistent noise alarm. Damage to the device was alleged. the device was explanted. No adverse patient consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262798 ↗MalfunctionAug 14, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261620 ↗MalfunctionAug 11, 2026Over-Sensing
During a remote follow-up, episodes of post-paced T-wave oversensing (PPTWO) were observed on the device. Reprogramming was recommended 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 50213079 ↗MalfunctionAug 11, 2026Over-Sensing
It was reported that the implantable cardioverter defibrillator exhibited post-paced t-wave oversensing. Programming changes were performed. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50204633 ↗MalfunctionAug 6, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161159 ↗MalfunctionJul 7, 2026Over-Sensing
DURING A REMOTE FOLLOW-UP, EPISODES OF POST-PACED T-WAVE OVERSENSING (PPTWOS) WAS WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND PROVIDED REPROGRAMMING RECOMMENDATIONS. THE DEVICE WAS THEN REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25732641 ↗InjuryJun 30, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT INAPPROPRIATE DEFIBRILLATION THERAPY WAS DELIVERED DUE TO INCORRECT INTERPRETATION OF ATRIAL FIBRILLATION. THE PHYSICIAN DIDN'T ALLEGE A MALFUNCTION AGAINST THE DEVICE AND ALLEGED THE DEVICE PERFORMED AS EXPECTED BASED ON THE PROGRAMMED SETTINGS. 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 25669143 ↗MalfunctionJun 30, 2026Over-Sensing; Device Sensing Problem
DURING A REMOTE FOLLOW-UP, POST-SENSED T-WAVE OVERSENSING (PSTWOS) AND DECREASED SENSING VARIATION WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING TO RESOLVE THE EVENT, HOWEVER NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25665302 ↗MalfunctionJun 22, 2026Over-Sensing
DURING FOLLOW-UP IN CLINIC, POST-PACED T-WAVE OVERSENSING EPISODES WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING TO RESOLVED 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 25579086 ↗MalfunctionJun 19, 2026Over-Sensing
DURING A REMOTE FOLLOW-UP, EPISODES OF POST-PACED T-WAVE OVERSENSING (PPTWO) WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING TO RESOLVED 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 25556707 ↗MalfunctionMay 27, 2026Over-Sensing
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T-WAVE OVERSENSING. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310837 ↗MalfunctionMay 27, 2026Over-Sensing
REPROGRAMMING WAS PERFORMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25304811 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.