Secura® VR D224VRCRecalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00613994446640), received between Apr 6, 2017 and Apr 1, 2025 — classified as 1 death, 65 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Failure to Charge” (26 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 101 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 9, 2023Failure to Charge; Electrical /Electronic Property Problem; Pacing Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Pacing Problem; Delayed Charge Time

  IT WAS FURTHER REPORTED THAT THE ICD TRIGGERED ALERTS FOR CHARGE CIRCUIT TIMEOUT, CHARGE CIRCUIT INACTIVE AND EXCESSIVE CHARGE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121707 ↗
• MalfunctionJan 6, 2023Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS A NORMAL BATTERY DEPLETION AND TRIGGERED END OF SERVICE (EOS) WITH A CHARGE CIRCUIT TIMEOUT. 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 16116942 ↗
• InjuryDec 19, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED ALERTS FOR CHARGE CIRCUIT TIMEOUTS, APPROXIMATELY 9 MONTHS AFTER REACHING STATUS OF RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE WAS PROGRAMMED OFF AND REMOVAL WILL BE EVALUATED WITH THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16007165 ↗
• MalfunctionOct 20, 2022Electrical /Electronic Property Problem; Failure to Interrogate; Electrical /Electronic Property Problem; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS) WITH NORMAL BATTERY DEPLETION AND COULD NOT BE INTERROGATED OR HAVE A MAGNET PLACED ON IT. THE PHYSICIAN HAD QUERIED WHY THE PATIENT COULD NOT UNDERGO MAGNETIC RESONANCE IMAGING (MRI) AND IT WAS NOTED THAT THE CONDITIONS FOR MRI LABELLING STATE NOT AT ELECTIVE REPLACEMENT INDICATOR (ERI). FOLLOW UP VIA THE PATIENT¿S FOLLOWING PHYSICIAN NOTED THAT AN ICD REPLACEMENT IS NOT PLANNED. THE ICD 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 15638256 ↗
• MalfunctionSep 7, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS BEEN AT END OF SERVICE (EOS) FOR THE LAST FEW YEARS AND THE PATIENT CHOSE NOT TO EXPLANT. THE DEVICE IS NOW ALERTING FOR CHARGE CIRCUIT INACTIVE. 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 15373217 ↗
• MalfunctionJun 14, 2022Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. IT IS SUSPECTED THAT THE OVERSENSING WAS DUE TO ELECTROMAGNETIC INTERFERENCE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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 14685565 ↗
• InjuryMay 11, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY LIFE WAS LESS THAN EXPECTED. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14359495 ↗
• InjuryMay 5, 2022Failure 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) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND ALERTED FOR A CHARGE CIRCUIT TIMEOUT. THE SAME DATE AS THE CHARGE CIRCUIT TIMEOUT THERE WAS ALSO AN ALERT FOR EXCESSIVE CHARGE TIME. 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 14286560 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ABOUT A WEEK AFTER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED THE IMPLANT SITE WAS SORE AND HAD A PALE DISCOLORATION. SEVERAL WEEKS LATER THE PATIENT HAD FEVER AND CHILLS. THE PATIENT WENT TO THE HOSPITAL. AT THE HOSPITAL IT WAS OBSERVED THAT PUSS OOZED FROM THE IMPLANT SITE WHEN PRESSURE WAS APPLIED. IT WAS FOUND THAT THE PATIENT HAD A STAPH INFECTION. ANTIBIOTICS WERE ADMINISTERED, AND THE ICD SYSTEM WAS EXPLANTED. AFTER THE EXPLANT THE PATIENT HAD INTERNAL BLEEDING AND MORE SURGERY WAS NEEDED. THE PATIENT WAS IN A COMA FOR ABOUT ONE MONTH. AFTER WAKING UP THE PATIENT REMAINED IN THE HOSPITAL DUE TO VENOUS INSUFFICIENCY IN THE BRAIN, AND SWELLING IN MULTIPLE AREAS OF THE BODY INCLUDING HEAD AND ARMS. THE PATIENT WAS EVENTUALLY DISCHARGED, AND LATER THE ICD SYSTEM WAS REPLACED.

  Patient problems: Bacterial Infection; Chills; Coma; Discomfort; Fever; Hemorrhage/Blood Loss/Bleeding; Purulent Discharge; Skin Discoloration; Swelling/ Edema; Valvular Insufficiency/ Regurgitation

  MAUDE report 14163652 ↗
• InjuryMar 11, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY HAD "DIED". THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13740521 ↗
• InjuryJan 31, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A CHARGE CIRCUIT TIMEOUT WITH THE DEVICE AT END OF SERVICE (EOS). THE DEVICE WAS PROGRAMMED OFF, AND REMAINS 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 13397337 ↗
• MalfunctionJan 27, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) APPROXIMATELY ONE AND A HALF YEARS AGO AND RECENTLY STARTED ALERTING FOR CHARGE CIRCUIT TIMEOUT. 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 13367156 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS LEFT INSIDE THE PATIENT¿S BODY AND WOULD NOT BE REMOVED DUE TO AN INFECTION. THE PATIENT HAD A NEW ICD SYSTEM IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12961799 ↗