Evera™ XT DR DDBB1D1 (UDI 00643169720404)Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00643169720404), received between May 3, 2018 and Aug 10, 2026 — classified as 2 deaths, 56 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (25 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 10, 2023Open, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1704-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Electromagnetic Interference

  It was reported that the patient stated that they had heard some beeping from their Implantable Cardioverter Defibrillator (ICD) believed to be Electromagnetic Interference. The patient had been working near some power tools and had noted that they may have had their phone in their breast pocket of their shirt. The patient did not note any symptoms. The ICD remains in use. The patient is a participant in a clinical study. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50198173 ↗
• MalfunctionMay 8, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. THE RA LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ELECTROMAGNETIC INTERFERENCE (EMI). 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 25124459 ↗
• InjuryFeb 26, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE HAD POTENTIALLY WITHHELD THERAPY DURING VENTRICULAR TACHYCARDIA (VT), THAT THE DEVICE CLASSIFIED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 24457052 ↗
• InjuryNov 20, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23610257 ↗
• MalfunctionNov 17, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT ATRIAL EVENTS APPEARED TO BE FALLING IN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR'S (ICD) BLANKING PERIOD AT TIMES, POSSIBLY TRIGGERING TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS WITH INAPPROPRIATE ATRIAL PACING NOTED AT TIMES. 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 23570038 ↗
• InjuryNov 14, 2025Failure to Deliver Shock/Stimulation; Pacing Problem; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POTENTIALLY INAPPROPRIATELY WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT) EPISODES THAT WERE CLASSIFIED AS SINUS TACHYCARDIA BY THE DEVICE DISCRIMINATOR. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 23560600 ↗
• InjuryOct 31, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY AND ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) VERSUS VENTRICULAR TACHYCARDIA (VT). IT WAS NOTED THAT IT APPEARS TO BE APPROPRIATELY INITIALLY DETECTED AS VT AND THEN EPISODE ACCELERATED TO VENTRICULAR FIBRILLATION (VF) ZONE POST ATP DELIVERY. ADDITIONALLY, IT WAS NOTED THAT THERE WAS POSSIBLE RHYTHM CHANGE POST ATP (ATRIAL ARRHYTHMIA WITH FAST VENTRICULAR RESPONSE). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR RVTIP TO RVCOIL LOW IMPEDANCE. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23438928 ↗
• InjuryAug 25, 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 WITH EROSION, PURULENT DISCHARGE/PUS, AND REDNESS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Erythema; Purulent Discharge; Unspecified Infection

  MAUDE report 22884760 ↗
• MalfunctionMar 5, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INTERROGATION REPORT SHOWED INVALID DATA FOR PACING PERCENTAGES AND RATE HISTOGRAMS. IT WAS NOTED THAT THE PATIENT HAD RADIATION THERAPY TO THE ESOPHAGUS ABOUT 1.5 YEARS AGO AND HASN¿T HAD A DEVICE CHECK UNTIL NOW. THE DEVICE DATA WAS REVIEWED BY RELEASED PRODUCT ENGINEERS WHICH INDICATED THAT THE INVALID DATA SIGNATURE WAS DUE TO DIAGNOSTIC BIT FLIPS CAUSED BY RADIATION EXPOSURE. 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 21526343 ↗
• InjuryOct 1, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED WITH VERY RAPID CONDUCTION VENTRICULAR RATES UP TO LOW 200S BEATS PER MINUTE (BPM) RATHER THAN VENTRICULAR TACHYCARDIA (VT) OR VENTRICULAR FIBRILLATION (VF). THE PATIENT WAS HOSPITALIZED AND TREATED WITH AN INCREASED DOSAGE OF MEDICATION AND REPROGRAMMING WAS PERFORMED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT'S ELECTROLYTES WERE ABNORMAL.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20346856 ↗
• InjurySep 28, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE THERAPY FOR AN EPISODE OF ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AS VENTRICULAR FIBRILLATION (VF). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20329167 ↗
• InjuryJun 14, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE RVR ASSOCIATED WITH INAPPROPRIATE SHOCK WAS AT RATES IN EXCESS OF 200 BEATS PER MINUTE (BPM).

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19539196 ↗
• MalfunctionApr 5, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT THAT AFTER THEY WERE TRAVELING, THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) "ALARM STARTED GOING OFF THREE TO FOUR DAYS AGO". THE PATIENT ALSO STATED THAT SINCE THE ICD WAS IMPLANTED, "IT WAS PUSHING ON [THE PATIENT'S] SKIN" TO THE POINT WHERE THE ICD HAS "SHIFTED" AND IS "LAYING FLATTER". THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19053920 ↗
• InjuryDec 21, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY DELIVERED SHOCKS AND ANTI-TACHYCARDIA PACING FOR ATRIAL TACHYCARDIA AND ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE. THE ICD MISCLASSIFIED THE EPISODE AS FAST VENTRICULAR TACHYCARDIA (FVT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18375356 ↗
• MalfunctionDec 15, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF FEELING DIZZY AND NAUSEOUS. A HEALTHCARE PROFESSIONAL (HCP) REQUESTED REVIEW OF AN IM PLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INTERROGATION AND THOUGHT THAT THERE MAY BE FAR FIELD R-WAVE (FFRW) OVERSENSING, PREMATURE ATRIAL CONTRACTIONS (PACS) OR RETROGRADE CONDUCTION. INFORMATION RECEIVED ON THE REMOTE TRANSMISSION WAS REVIEWED BY QUALIFIED PERSONNEL. IT WAS SUGGESTED THAT THE REPORT INDICATED POTENTIAL RETROGRADE CONDUCTION. PROGRAMMING OPTIONS WERE PRESENTED AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Nausea

  MAUDE report 18334589 ↗
• InjuryNov 21, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED A SHOCK FOR A DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODE THAT WAS POSSIBLE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE ICD AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 18182946 ↗
• InjurySep 28, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA AND COMPLETE HEART BLOCK WITH ASSOCIATED DIZZINESS AND SHORTNESS OF BREATH. A PACING PROBLEM WAS NOTED WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AS IT WAS NOT CAPTURING DESPITE LOW LEAD THRESHOLDS AND AN APPROPRIATE PROGRAMMED OUTPUT. IN ADDITION, THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED FRACTURE OF THE HIGH VOLTAGE COIL, TRIGGERED A LEAD INTEGRITY ALERT (LIA) AND EXHIBITED NOISE. IN ADDITION, INTERMITTENT CAPTURE WAS NOTED. THE ICD WAS EXPLANTED AND REPLACED AND THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness; Dyspnea; Heart Block

  MAUDE report 17835461 ↗
• InjuryMay 15, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AN INTERROGATION SHOWED THAT SIX SHOCKS WERE DELIVERED FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. BASED ON MORPHOLOGY AND THE CONDUCTION PATTERN, IT WAS SUSPECTED THAT THE RHYTHM MAY HAVE BEEN SUPRA VENTRICULAR TACHYCARDIA (SVT), AND THERAPIES MAY HAVE BEEN DELIVERED INAPPROPRIATELY. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 16929903 ↗
• MalfunctionMay 4, 2023Premature Discharge of Battery; Incorrect Measurement; Communication or Transmission Problem; Premature Discharge of Battery; Incorrect Measurement; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECT OF A PREMATURE BATTERY DEPLETION. THE DEVICE HAS BEEN GIVING ODD BATTERY VOLTAGE MEASUREMENT THAT HAD BEEN DROPPING CONSISTENTLY. THE DEVICE IS ALERTING AND WAS UNABLE TO SEND A TRANSMISSION WITH THE REMOTE MONITOR TO THE REMOTE MONITORING 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 16872524 ↗
• InjuryApr 18, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 16760805 ↗
• InjuryNov 24, 2022Adverse 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 INFECTION AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15860333 ↗
• InjuryOct 5, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE EXPERIENCED INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 15546799 ↗
• MalfunctionAug 10, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED THAT SHORT CIRCUIT PROTECTION OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY. ADDITIONALLY IT WAS NOTED THAT SIX MONTHS PRIOR A DROP IN IMPEDANCE WAS NOTED ACROSS ALL CHANNELS THAT EVENTUALLY BEGAN TO RISE TO WITHIN NORMAL LIMITS. THE DEVICE AND LEADS 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 15201793 ↗
• InjuryJul 11, 2022Adverse 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 REMOVED DUE TO INFECTION. IT WAS FURTHER REPORTED THAT AN ANTIBIOTIC TREATMENT WAS NECESSARY. THE SYSTEM WAS SUBSEQUENTLY REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 14976972 ↗
• MalfunctionMar 3, 2022Unable to Obtain Readings; Device-Device Incompatibility; Unable to Obtain Readings; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT STORE EPISODES OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) ON THE DAY THE PATIENT HAD AN MAGNETIC RESONANCE IMAGING (MRI). THE MISSING DATA WAS SUSPECTED TO BE DUE TO ELECTROMAGNETIC INTERFERENCE CAUSED BY THE MRI. 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 13662812 ↗