Entrant™ CDVRA300TRecalls & reported problems
St. Jude Medical, Inc. · VR Implantable Cardioverter Defibrillator · Class 3 · Implant
All models of Entrant (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067049414), received between May 13, 2025 and Mar 13, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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
- Connection Problem2
- Break1
- High impedance1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Connection Problem
IT WAS REPORTED THAT DURING DEVICE REPLACEMENT, THE LEAD COULD NOT BE INSERTED IN THE HEADER OF THE DEVICE. THE DEVICE COULD NOT BE IMPLANTED. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24594587 ↗MalfunctionDec 22, 2025Connection Problem; Connection Problem
DURING AN ELECTIVE REPLACEMENT PROCEDURE, IT WAS NOT POSSIBLE TO FIXATE THE OLD LEAD INTO THE HEADER OF THE REPLACEMENT DEVICE. THE REPLACEMENT DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23864723 ↗MalfunctionMay 13, 2025Break; High impedance; Loose or Intermittent Connection; Break; High impedance; Loose or Intermittent Connection
IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE, THE SET SCREW OF THE DEVICE WAS UNABLE TO BE TIGHTENED RESULTING IN HIGH PACING IMPEDANCE. ADDITIONAL ATTEMPTS WERE MADE TO TIGHTEN THE SET SCREW AND MIGRATION OF THE HEADER SEPTUM AND THE SET SCREW WITHIN THE DEVICE HEADER WAS OBSERVED. 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 22009641 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 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.
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