Secura VRRecalls & reported problems across all models

We found 2 models of Secura VR by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 115 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2017 and Apr 1, 2025 — classified as 1 death, 78 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Failure to Charge” (28 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. 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

Most reported Secura VR problems

Secura VR models

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

• Secura® VR D224VRC

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death101 reports
• Secura® VR D204VRM

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

Recent Secura VR adverse event reports

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

• MalfunctionApr 1, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS ADVISED TO GET IN CONTACT WITH CARDIOLOGIST FOR A DEVICE CHECK. NO FURTHER INFORMATION COULD BE OBTAINED THROUGH FOLLOW-UP. THE MOBILE MONITORING APPLICATION AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748775 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO A POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21473790 ↗
• InjuryAug 9, 2024Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) TWO YEARS AGO. THE ICD WAS NOW AT END OF SERVICE (EOS) AND CHARGE CIRCUIT INACTIVE OCCURRED. ALERTS WERE TRIGGERED FOR CHARGE CIRCUIT TIMEOUT AND FOR A LONG CHARGE TIME GREATER THAN 30 SECONDS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD CAPTURE THRESHOLD WAS UNAVAILABLE, AND CAPTURE COULD NOT BE CONFIRMED. THE RV LEAD REMAINS IN USE, AND THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19954136 ↗
• InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19680269 ↗
• MalfunctionApr 10, 2024Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT HAD FELL AND THEIR DEVICE REACHED END OF SERVICE (EOS) AND TRIGGERED ALERTS FOR LONGER THAN EXPECTED CHARGE TIME AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND CHARGE CIRCUIT TIMEOUT. ADDITIONALLY, THE DEVICE EXHIBITED CHARGE CIRCUIT INACTIVE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081934 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18995724 ↗
• InjuryJan 12, 2024Failure to Charge; Delayed Charge Time; Failure to Charge; Delayed Charge Time

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504394 ↗
• MalfunctionOct 27, 2023Battery Problem; Communication or Transmission Problem; Reset Problem; Battery Problem; Communication or Transmission Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI)/ RECOMMENDED REPLACEMENT TIME (RRT) SEVERAL YEARS AGO AND WAS ELECTIVELY LEFT IN USE WELL AFTER ERI/RRT. THE DEVICE HAD REACH END OF SERVICE (EOS). THE DEVICE WAS NOTED TO HAVE AN ELECTRICAL RESET AND WIRELESS TELEMETRY WAS NO LONGER AVAILABLE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18025211 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS, METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS AND BACTEREMIA. IT WAS NOTED THAT THE INFECTION SOURCE WAS SUSPECTED TO BE A CHEMOTHERAPY PORT; HOWEVER, VEGETATION WAS NOTED ON THE ICD SYSTEM. A NEW ICD SYSTEM WAS IMPLANTED A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Endocarditis

  MAUDE report 17977545 ↗
• MalfunctionJul 31, 2023Failure to Charge; Protective Measures Problem; Failure to Charge; Protective Measures Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTED DUE TO A CHARGE CIRCUIT TIMEOUT. IT WAS NOTED THAT THE DEVICE HAD REACHED END OF SERVICE (EOS) THREE YEARS PRIOR. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17425372 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION OF UNKNOWN ORIGIN WITHIN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET. THE ICD SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17218339 ↗
• MalfunctionMay 22, 2023Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT HEARING A BEEPING NOISE FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT MENTIONED THAT THE DEVICE WAS DUE FOR A CHANGE OUT SEVERAL YEARS AGO AND THE PATIENT CHOSE TO LEAVE THE DEVICE IMPLANTED AND JUST TURN OFF THE DEVICE. THE DEVICE ALERTED FOR A CHARGE CIRCUIT TIMEOUT AND HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) WITH ALL DETECTIONS PROGRAMMED OFF. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974550 ↗
• MalfunctionMay 15, 2023Failure to Charge; Failure to Charge

  IT WAS REPORTED, THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS BEEN AT END OF SERVICE (EOS). FOR A CONSIDERABLE AMOUNT OF TIME SINCE THE PATIENT AND CARDIOLOGIST DECIDED, THAT THE ICD SHOULD BE TURNED OFF, AND NOT REPLACED/REMOVED. AS A RESULT OF THE DEVICE AGE, THE CHARGE CIRCUIT TIMEOUT IS NOW OCCURRING. THE DEVICE REMAINS INACTIVATED. AND IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16932054 ↗
• InjuryMay 3, 2023Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT AFTER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS) A CHARGE CIRCUIT INACTIVE AND CHARGE CIRCUIT OCCURRED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863026 ↗
• MalfunctionApr 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE YEARS AFTER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED RECOMMENDED REPLACEMENT TIME (RRT), IT TRIGGERED AN ALERT DUE TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NOT HAVING ENOUGH ENERGY TO FORM THE CAPACITORS. THE PATIENT OPTED TO HAVE THE DEVICE REMOVED AND THE DEVICE WAS LATER EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732847 ↗

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