Evera™ XT VR DVBB1D1 (UDI 00643169530300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169530300), received between Feb 9, 2017 and Sep 18, 2025 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (6 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. Feb 3, 2021Open, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1305-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO A TRUE VENTRICULAR ARRHYTHMIA. THIS CAUSED THE DETECTION INTERVAL TO INCREASE AND DELAYED HIGH VOLTAGE THERAPY FOR VENTRICULAR FIBRILLATION (VF). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 23089315 ↗
• InjuryApr 3, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED BECAUSE IT WAS DAMAGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767724 ↗
• InjuryFeb 29, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT A REMOTE MONITORING TRANSMISSION INDICATED THAT THE PATIENT POSSIBLY RECEIVED INAPPROPRIATE SHOCKS FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. 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 18812980 ↗
• InjuryJun 15, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD RAPID BATTERY DEPLETION. THE LEAD 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 17134950 ↗
• InjuryMar 9, 2023Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT (LIA) ON THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED BY HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS ALSO NOTED THAT THERE WAS OVERSENSING ON THE RV LEAD. IT WAS NOTED THAT THE OVERSENSING OCCURRED WHILE THE PATIENT WAS IN SURGERY FOR A HIP REVISION. IT WAS FURTHER CLARIFIED THAT THE LIA AND OVERSENSING WERE RELATED TO NOISE FROM THE SURGERY THE PATIENT WAS UNDERGOING AT THAT TIME. A MAGNET WAS PLACED OVER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INITIALLY BUT SLIPPED OFF, AND THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DURING THE REMAINDER OF THE PROCEDURE DUE TO THE OVERSENSING OF NOISE. THE ICD AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 16515864 ↗
• InjuryFeb 21, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PREMATURE BATTERY DEPLETION. 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 16409202 ↗
• MalfunctionOct 24, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INDICATED THAT SHORT CIRCUIT PROTECTION WAS TRIGGERED DURING HIGH VOLTAGE THERAPY. THIS RESULTED IN LESS THAN THE PROGRAMMED HIGH VOLTAGE ENERGY BEING DELIVERED, HOWEVER THE ARRHYTHMIA WAS SUCCESSFULLY TERMINATED. 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 15661933 ↗
• InjuryAug 31, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT WAS NOT TAKING THEIR ARRHYTHMIA MEDICATIONS AND EXPERIENCED MULTIPLE APPROPRIATE SHOCKS, REPORTED AS A VENTRICULAR TACHYCARDIA (VT) STORM. THE DEVICE HAD PREMATURE BATTERY DEPLETION. 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 15329468 ↗
• InjuryOct 11, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY A FRIEND OR FAMILY MEMBER OF THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WOULD SHOCK THE PATIENT WHEN IT WAS NOT NEEDED. THEY FURTHER MENTIONED THAT THE PATIENT HAD AN ABLATION AND THAT THIS HAD NOT OCCURRED SINCE. THE PATIENT WAS REFERRED TO THEIR PHYSICIAN. 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 12611481 ↗
• MalfunctionAug 17, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PREMATURE RAPID BATTERY DEPLETION. 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 12333174 ↗
• InjuryFeb 8, 2021Adverse 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. A NEW SYSTEM WILL NOT BE IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11293344 ↗
• InjuryFeb 5, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION AND THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8304550 ↗
• InjuryApr 25, 2018Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing

  IT WAS REPORTED THAT A REVIEW OF THE REMOTE TRANSMISSION INDICATED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS AND A LEAD INTEGRITY ALERT WAS TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO LEAD IMPEDANCE, OVERSENSING, AND SENSING INTEGRITY COUNTER (SIC). THERE WAS ALSO RV LEAD IMPEDANCES WARNINGS TRIGGERED FOR HIGH PACING IMPEDANCE AND A RV LEAD NOISE WARNING TRIGGERED. ADDITIONALLY,THERE WERE HIGH RATE NON-SUSTAINED EPISODES NOTED ON THE INTERROGATION REPORT. A POSSIBLE LEAD FRACTURE WAS SUSPECTED. THE RV LEAD WAS PROGRAMMED OFF. IT WAS ALSO QUESTIONED WHY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT WITHHOLD THE INAPPROPRIATE SHOCKS. THE FOLLOWING DAY THE RV LEAD WAS CAPPED AND REPLACED. 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 7459644 ↗
• InjuryApr 10, 2018Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED DUE TO ATRIAL DRIVEN ARRHYTHMIAS DETECTED AS VENTRICULAR FIBRILLATION (VF) BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT¿S FAMILY MEMBER CALLED TO REPORT AN INAPPROPRIATE SHOCK WITH THE PATIENT ENDING UP IN THE EMERGENCY ROOM (ER). THE PATIENT¿S FAMILY MEMBER REPORTS THE PATIENT HAVING ATRIAL FIBRILLATION (AF) AND SYMPTOMS OF DIZZINESS. A FOLLOW UP WITH THE PATIENT¿S HEALTHCARE PROVIDER YIELDED THAT THE ICD WAS REPROGRAMMED AND THE ISSUE WAS RESOLVED. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Dizziness; Shock from Patient Lead(s)

  MAUDE report 7413888 ↗
• MalfunctionAug 9, 2017Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT DURING IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PROGRAMMER LOST TELEMETRY WITH THE DEVICE. AFTER THE LEAD WERE CONNECTED TO THE DEVICE IMPEDANCE READINGS COULD NOT BE OBTAINED. THE LEAD WERE CONNECTED TO THE OLD DEVICE AND IMPEDANCE READINGS WERE NORMAL. THE PHYSICIAN DID NOT USE THE DEVICE AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6783329 ↗
• InjuryAug 9, 2017Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing

  IT WAS REPORTED THAT THE PATIENT HAD BEEN DOING WELL BUT THEN FELT POORLY AND WAS ADMITTED AFTER RECEIVING MULTIPLE (B)(6) ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR) INAPPROPRIATE SHOCKS FOR ATRIAL ARRHYTHMIAS. AN ECHOCARDIOGRAM SHOWED THE PATIENT HAD LOW EJECTION FRACTION. THE PATIENT WAS TREATED WITH IV (INTRAVENOUS) AMIODARONE AND HEPARIN AND CONVERTED TO SINUS RHYTHM. THE PATIENT LATER HAD A SVT (SUPRA VENTRICULAR TACHYCARDIA) ABLATION PROCEDURE. THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE WORLD-WIDE RANDOMIZED ANTIBIOTIC ENVELOPE INFECTION PREVENTION TRIAL CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined; Shock from Patient Lead(s)

  MAUDE report 6780741 ↗
• InjuryAug 9, 2017Mechanical Problem; Over-Sensing; Mechanical Problem; Over-Sensing

  IT WAS REPORTED THAT WITHIN ONE MONTH OF IMPLANT, NOISE WAS OBSERVED ON THE PACE SENSE PORTION OF THE RIGHT VENTRICULAR LEAD. IT WAS SUSPECTED THAT IT MIGHT BE A SET SCREW OR LEAD PIN NOT ALL THE WAY OUT. DURING THE REVISION PROCEDURE, THE LEAD WAS REMOVED FROM THE HEADER AND THE LEAD TESTED NORMALLY. THE CONNECTOR PIN WAS VISUALIZED UNDER FLUOROSCOPY. TESTING WAS PERFORMED POST POCKET IMPLANT. BOTH THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6779612 ↗
• InjuryFeb 9, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT FELT A SHOCK ¿ SELF-DESCRIBED AS A "TINGLE ALL OVER [THE PATIENT'S] BODY" ¿ AFTER WHICH AN AUDIBLE ALERT TONE WAS HEARD. FROM AN INTERROGATION THREE DAYS LATER, INTERMITTENT T-WAVE OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR(RV) LEAD, AND A CHANGE TO RV SENSITIVITY WAS RECOMMENDED. APPROXIMATELY THREE WEEKS LATER, THE PATIENT REPORTED EXPERIENCING MULTIPLE SHOCKS PER DAY WITH ¿TINGLING.¿ THE PATIENT ALSO REPORTED HAVING HAD AN INFECTION AFTER IMPLANT. THE DEVICE AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 6317017 ↗