Protecta XT VRRecalls & reported problems across all models

We found 3 models of Protecta XT VR by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 209 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2017 and May 6, 2026 — classified as 4 deaths, 151 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (43 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 Protecta XT VR problems

Protecta XT VR models

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

• Protecta™ XT VR D314VRG

  Implantable cardioverter defibrillator (non-CRT)
  4 deaths134 reports
• Protecta™ XT VR D314VRM

  Implantable cardioverter defibrillator (non-CRT)
  64 reports
• Protecta™ XT VR D314VRG

  Implantable cardioverter defibrillator (non-CRT)
  11 reports

Recent Protecta XT VR adverse event reports

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

• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND THE RIGHT VENTRICULAR (RV) LEAD WAS TAKEN OUT OF SERVICE. TWO MONTHS LATER A NEW ICD SYSTEM WAS IMPLANTED. THE LEAD STATUS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25096176 ↗
• MalfunctionFeb 17, 2026Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TONED DUE TO A CHARGE CIRCUIT TIMEOUT AFTER PREVIOUSLY BEING PROGRAMMED OFF. 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 24369030 ↗
• InjuryFeb 10, 2025Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT). APPROXIMATELY THREE MONTHS LATER, THE ICD EXHIBITED EXCESSIVE CHARGE TIME AND IT WAS NOTED THE DEVICE WAS AT END OF SERVICE (EOS). 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 21345600 ↗
• MalfunctionJan 13, 2025Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED EXCESSIVE CHARGE TIME. THE DEVICE HAS SINCE REACHED END OF SERVICE (EOS) AND 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 21138365 ↗
• MalfunctionNov 26, 2024Failure to Charge; Failure to Charge

  IT WAS REPORTED, THAT THERE WAS A CHARGE CIRCUIT TIMEOUT ON A DEVICE. THAT WAS AT END OF SERVICE (EOS). THE PATIENT ELECTED TO NOT REPLACE THE DEVICE. AND IT 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 20781446 ↗
• InjuryAug 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR DEVICE HAD TO BE REPLACED DUE TO AN UNSPECIFIED MALFUNCTION. NO FURTHER INFORMATION COULD BE OBTAINED THROUGH FOLLOW-UP WITH THE CLINIC. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986197 ↗
• MalfunctionJun 25, 2024Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO A SUSPECTED LOW VOLTAGE FRACTURE OF THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND ELEVATED SENSING INTEGRITY COUNTER (SIC). SEVERAL ALERTS WERE TRIGGERED FOR LEAD NOISE AND HIGH/UNDEFINED PACING IMPEDANCE. THE PATIENT WAS HOSPITALIZED AND THE ICD FUNCTION WAS TURNED OFF AS IT WAS NOTED THE PATIENT IS CURRENTLY IN HOSPICE. THE SYSTEM REMAINS IN-SITU CURRENTLY AS THE PHYSICIAN IS DETERMINING NEXT STEPS DUE TO PATIENT'S PRE-EXISTING CONDITIONS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED A VARIATION IN PACING IMPEDANCE MEASUREMENTS, AND OVERSENSING. IN ADDITION, THE DEVICE REACHED END OF SERVICE (EOS), AND A CHARGE CIRCUIT TIMEOUT OCCURRED. THE CHARGE CIRCUIT WAS INACTIVE, AND THE PATIENT REFUSED TO HAVE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610026 ↗
• MalfunctionApr 22, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY WITH THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) . TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO THE CLINIC. THE MONITOR AND ICD REMAIN IN USE. NOPATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154503 ↗
• MalfunctionApr 15, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED, THAT THE PATIENT HAD A DECREASED HEART RATE. IT WAS FOUND, THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PACING BELOW THE PROGRAMMED LOWER RATE. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 19111051 ↗
• MalfunctionFeb 7, 2024Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS AT END OF SERVICE (EOS) AND TRIGGERED A CHARGE CIRCUIT INACTIVE ALERT. IT WAS LATER REPORTED THAT A CHARGE CIRCUIT TIMEOUT OCCURRED. 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 18661543 ↗
• InjuryNov 16, 2023Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED.

  Patient problems: Bradycardia

  MAUDE report 18156421 ↗
• InjuryOct 31, 2023Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTED FOR CHARGE CIRCUIT INACTIVE. THE DEVICE HAD BEEN AT END OF SERVICE (EOS) FOR SEVERAL YEARS. 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 18039982 ↗
• MalfunctionSep 28, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO DO THE TELEMETRY AFTER THEY RECEIVED THE REMOTE MONITOR. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO CLINIC. THE REMOTE MONITOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2023, IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO SEND A MANUAL TRANSMISSION THROUGH THE REMOTE MONITOR TO THE REMOTE MONITOR NETWORK. 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 17834756 ↗
• InjurySep 21, 2023Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS AND SHORTNESS OF BREATH. THERE WAS EXTERNAL ELECTROMAGNETIC INTERFERENCE (EMI) NOTED IN THE CAN TO SUPERIOR VENA CAVA (SVC) VECTOR. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Muscle Weakness/Atrophy

  MAUDE report 17787985 ↗
• MalfunctionMay 23, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS). THE PATIENT AND PHYSICIAN ELECTED TO KEEP THE ICD IMPLANTED. THE DEVICE TRIGGERED AN ALERT FOR CHARGE CIRCUIT INACTIVE. ALERTS WERE PROGRAMMED OFF AND 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 16984074 ↗

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