Secura DRRecalls & reported problems across all models

We found 2 models of Secura DR by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 218 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Aug 12, 2025 — classified as 1 death, 152 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Delayed Charge Time” (37 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 DR problems

Secura DR models

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

• Secura® DR D224DRG

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death194 reports
• Secura® DR D204DRM

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

Recent Secura DR adverse event reports

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

• InjuryAug 12, 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) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22783492 ↗
• MalfunctionNov 18, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED, RAISING CONCERNS ABOUT THE POSSIBILITY OF THE DEVICE HAVING NO BATTERY LEFT. THE PATIENT WAS LOST TO FOLLOW-UP, AND THERE WAS A POSSIBILITY THAT THE PATIENT HAD THEIR DEVICE REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THE INABILITY TO INTERROGATE THE DEVICE WAS ATTEMPTED IN-OFFICE USING MULTIPLE PROGRAMMERS, BUT IT WAS EXPLAINED THAT THE OLDER DEVICE MIGHT NOT HAVE ENOUGH BATTERY LEFT TO ALLOW INTERROGATION. 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 20706867 ↗
• InjuryJan 25, 2024Device Alarm System; Failure to Interrogate; Device Alarm System; Failure to Interrogate

  IT WAS REPORTED THAT WHEN TRYING TO INTERROGATE THE PATIENT¿S DEVICE WITH A MONITOR A "NO DEVICE FOUND" MESSAGE POPULATED. THE DEVICE WAS ATTEMPTED TO BE INTERROGATED MULTIPLE TIMES WITH THE MONITOR, BUT ONLY ONE ATTEMPT WAS OPERABLE. IT WAS ALSO NOTED THAT WHEN A MAGNET WAS PLACED OVER THE DEVICE NO TONES WERE EMITTED. THE PATIENT WAS IN PERSISTENT VENTRICULAR TACHYCARDIA (VT). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 18582318 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REMOVED DUE TO A NEAR EROSION AT THE IMPLANT SITE. A NEW DEVICE WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 17999362 ↗
• InjuryOct 23, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS APPREHENSIVE TO HAVE AN MAGNETIC RESONANCE IMAGING (MRI) AFTER BEING SHOCKED NINE TIMES IN THE PAST BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). FOLLOW UP WAS CONDUCTED WITH THE PATIENT'S FOLLOWING PHYSICIAN AND IT WASNOTED THAT THE SHOCKS THE PATIENT RECEIVED IN THE PAST WERE FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE DEVICE REMAINED IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17987655 ↗
• InjuryOct 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR PREVIOUS DEVICE JUST STOPPED WORKING AND WAS REPLACED TWO DAYS LATER. A FOLLOW-UP INVESTIGATION DID NOT PROVIDE ANY ADDITIONAL DETAILS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 17935671 ↗
• MalfunctionSep 14, 2023Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS) AND HAD AN ELECTRICAL RESET. WIRELESS TELEMETRY IS NO LONGER AVAILABLE ON THIS DEVICE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED ASA RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744917 ↗
• InjuryAug 23, 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 AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17603851 ↗
• MalfunctionJul 11, 2023Electrical /Electronic Property Problem; Delayed Charge Time; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ELECTROPHYSIOLOGIST AFTER BEING LOST TO FOLLOW-UP AND THEIR DEVICE WELL PAST ELECTIVE REPLACEMENT INDICATOR (ERI). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO HAVE AN ALERT TONE PLAYING UPON INTERROGATION, AND A WARNING DISPLAYED STATING, "CHARGE CIRCUIT INACTIVE".  THERE WAS ALSO AN ALERT FOR EXCESSIVE CHARGE TIME NOTED. THE DEVICE HAS SINCE REACHED END OF SERVICE (EOS) STATUS. THE ALERTS WERE PROGRAMMED OFF, AND 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 17297969 ↗
• InjuryApr 26, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE REACHED NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) AND HAD NO TELEMETRY. 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 16815339 ↗
• MalfunctionMar 31, 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 AN ELECTRICAL RESET OCCUR. IT WAS ALSO NOTED THAT AN ALERT WAS TRIGGERED FOR THE ICD REACHING END OF SERVICE (EOS) AND THAT WIRELESS TELEMETRY WAS NO LONGER AVAILABLE. THE ICD REMAINS IN-SITU. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656894 ↗
• InjuryMar 29, 2023Failure 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) TRIGGERED AN ALERT FOR AN INACTIVE CHARGE CIRCUIT AFTER THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT). ADDITIONALLY, THE ICD HAD A CHARGE CIRCUIT TIMEOUT AND A LONGER THAN EXPECTED 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 16639624 ↗
• InjuryMar 24, 2023Failure 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) ALERTED FOR CHARGE TIME THAT WAS LONGER THAN EXPECTED. THE DEVICE HAD A CHARGE CIRCUIT TIMEOUT ALERT AND A CHARGE CIRCUIT INACTIVE ALERT. THE DEVICE WAS AT END OF SERVICE (EOS). 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 16612670 ↗
• MalfunctionJan 11, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED, AND NO DEVICE TONES WERE EMITTED WHEN PLACING A PROGRAMMER HEAD OVER IT. WITH THE WAND PLACED OVER THE DEVICE, A GREEN LIGHT HAD FLASHED MOMENTARILY, THEN WENT AWAY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 16139606 ↗
• MalfunctionNov 10, 2022Failure to Charge; Charging Problem; Failure to Charge; Charging Problem

  IT WAS REPORTED THAT THE DEVICE REACHED END OF SERVICE (EOS) AND ALERTED FOR CHARGE CIRCUIT TIMEOUT. THE PATIENT HAS ELECTED TO KEEP THE DEVICE IMPLANTED, WITH ALL ALERTS PROGRAMMED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771802 ↗

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