Entrant™ CDHFA300TRecalls & reported problems
St. Jude Medical, Inc. · HF Cardiac Resynchronization Therapy Defibrillator · Class 3 · Implant
All models of Entrant (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067049513), received between May 30, 2025 and Aug 26, 2026 — classified as 1 death, 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “High impedance” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- High impedance2
- Over-Sensing2
- Connection Problem1
- Inappropriate or Unexpected Reset1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
DeathAug 26, 2026High impedance; Over-Sensing
It was reported that increased pacing impedance was observed on the left ventricular (LV) and right ventricular (RV) channels of the device. Additionally, episodes of noise resulting in oversensing were observed on the RV channel. The cause of the event was not alleged. While attempting to gather additional information, it was found that the patient passed away. The circumstances of the patient death are not known. Additional information as requested but not yet received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457288 ↗InjuryJun 23, 2026High impedance; Connection Problem
IT WAS REPORTED THAT AN INCREASE IN PACING IMPEDANCE WAS OBSERVED ON THE DEVICE. THE LEFT VENTRICULAR (LV) LEAD WAS ALLEGED TO BE INADEQUATELY INSERTED INTO THE DEVICE HEADER. DURING A REVISION PROCEDURE, THE LV LEAD WAS DETACHED AND REATTACHED BACK INTO THE DEVICE HEADER TO RESOLVE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25600725 ↗MalfunctionApr 5, 2026Over-Sensing
IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING (PPTWOS). PROGRAMMING CHANGES WERE MADE BUT WERE UNABLE TO RESOLVE THE ISSUE. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787027 ↗MalfunctionMay 30, 2025Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND IN BACK-UP MODE. NO INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22117148 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page