Quadra Assura™ CD3265-40QRecalls & reported problems

Summary

The FDA's MAUDE database contains 359 adverse event reports that list this exact device (DI 05414734505673), received between Jun 10, 2018 and Mar 4, 2026 — classified as 12 deaths, 154 injuries, 193 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (145 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 359 reports, in the reporter's own words as published by the FDA.

• DeathMar 4, 2026Adverse Event Without Identified Device or Use Problem

  VOLUNTARY MEDWATCH RECEIVED STATES THAT THE PATIENT DIED. THE PATIENT HAD AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507617 ↗
• InjuryFeb 27, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT PRIOR TO GENERATOR CHANGEOUT, THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED FAR R-WAVE OVER-SENSING. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT'S HEALTH STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441608 ↗
• DeathJun 28, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  VOLUNTARY MEDWATCH RECEIVED STATES THAT THERE WAS NO OUTPUT FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT IS DECEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841718 ↗
• MalfunctionJun 22, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PROCEDURE THAT THERE WAS DIFFICULTY TO REMOVE SET SCREW FROM THE HEADER OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN EXPLANTED AND REPLACED THE ICD. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775429 ↗
• InjuryJun 1, 2022Premature Discharge of Battery; Premature Discharge of Battery

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565628 ↗
• InjuryMay 12, 2022Premature Discharge of Battery; Premature Discharge of Battery

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND AWAITING EXPLANT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14381260 ↗
• InjuryMay 6, 2022Premature Discharge of Battery; Premature Discharge of Battery

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310554 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A SUBCUTANEOUS RELOCATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET DUE TO CHRONIC PAIN ISSUES. THE PHYSICIAN EXPLANTED AND REPLACED THE ICD. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER THE PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 14116521 ↗
• MalfunctionFeb 3, 2022Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 13445383 ↗
• MalfunctionJan 14, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET WITH NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) DUE TO POST-PACED T-WAVE OVERSENSING (PPTWOS) ON THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO CHANGES OR INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261917 ↗
• InjuryDec 17, 2021Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED DIAPHRAGM STIMULATION. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE DEVICE. THE PATIENT CONDITION WAS STABLE.

  Patient problems: Discomfort

  MAUDE report 13028842 ↗
• MalfunctionDec 10, 2021Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT INTO CLINIC, AS AN ELECTROCARDIOGRAM SHOWED THEY MAY BE OVERSENSING AND NOT PACING AT THEIR LOWER RATE LIMIT. INTERROGATION REVEALED POST PACED T WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE. NO ADDITIONAL OVERSENSING WAS OBSERVED AFTER PROGRAMMING. THERE WERE NO PATIENT SYMPTOMS DUE TO THE OVERSENSING. THE PATIENT WAS TO CONTINUE BEING MONITORED FROM HOME. THE PATIENT WAS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12980922 ↗
• InjuryDec 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-38432, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-38433. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A FOLLOW-UP. DURING EXAMINATION, IT WAS NOTED THAT THERE WAS INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL LEAD AND LEFT VENTRICULAR LEADS WERE EXPLANTED ON (B)(6) 2021. THE PATIENT CONDITION IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12931850 ↗
• InjuryDec 1, 2021Premature Discharge of Battery; Premature Discharge of Battery

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913404 ↗
• MalfunctionNov 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Data Problem; Incorrect, Inadequate or Imprecise Result or Readings; Data Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA (B)(6) . UPON REVIEW OF THE TRANSMISSION, THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND TO HAVE ABNORMAL ELECTROGRAMS (EGMS) AND EXHIBITED ABNORMAL DATA CORRUPTION ON THE DEVICE SETTINGS. CORRECTIVE PROGRAMMING CHANGES WERE MADE. NO PATIENT CONSEQUENCES WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788269 ↗
• MalfunctionAug 27, 2021Intermittent Capture; Over-Sensing; Intermittent Capture; Over-Sensing

  IT WAS REPORTED THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC. UPON INTERROGATION, IT WAS OBSERVED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS OVERSENSING AS A RESULT OF INTERMITTENT BIVENTRICULAR CAPTURE. PROGRAMMING CHANGES WERE RECOMMENDED BUT NOT YET COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380527 ↗
• InjuryAug 10, 2021Premature Discharge of Battery; Premature Discharge of Battery

  NEW INFORMATION RECEIVED NOTES THE DEVICE WAS EXPLANTED AND REPLACED. DEVICE FUNCTION WAS NORMAL HOWEVER THE DEVICE WAS ON ADVISORY AND HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR. THERE WAS NO LOSS OF PACING OR BATTERY PERFORMANCE ALERT. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12301831 ↗
• InjuryJul 1, 2021Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104996 ↗
• MalfunctionJul 1, 2021Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC. UPON PRESENTING, IT WAS FOUND THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED LOSS OF RADIO FREQUENCY TELEMETRY, WITH ONLY INDUCTIVE TELEMETRY POSSIBLE. A CORRECTIVE CYBER SECURITY UPGRADE WAS PERFORMED ON (B)(6) 2021 WHICH RESTORED RADIO FREQUENCY TELEMETRY FUNCTION. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104362 ↗
• MalfunctionJun 23, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOTED TO FALSELY SWITCH TO BACKUP VVI (BVVI) MODE. THE PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053403 ↗
• MalfunctionJun 4, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2021 PREVIOUS EPISODES OF POST-PACED T-WAVE OVERSENSING ON THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THAT WAS FIRST NOTED (B)(6) 2020. PROGRAMMING CHANGES WERE MADE DURING THE IN-CLINIC VISIT. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939910 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE ADVISORY FOR PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ALTHOUGH THERE WAS NO ERI ALERT OR ALLEGATION OF PREMATURE BATTERY DEPLETION, THE DEVICE WAS EXPLANTED PROPHYLACTICALLY. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11844812 ↗
• InjuryMay 11, 2021Premature Discharge of Battery; Premature Discharge of Battery

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. THE PATIENT WAS DISCHARGED POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810091 ↗
• InjuryMar 24, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE GENERATOR REPLACEMENT PROCEDURE. PRIOR TO THE PROCEDURE, INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR REVEALED THAT THERE WAS MYOPOTENTIAL OVERSENSING SEEN ON THE RIGHT VENTRICULAR CHANNEL. THE PATIENT WAS IN STABLE CONDITION AND THE EXPLANT OCCURRED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564447 ↗
• InjuryMar 22, 2021Premature Discharge of Battery; Failure to Capture; Low impedance; Premature Discharge of Battery; Failure to Capture; Low impedance

  IT WAS REPORTED THAT PRIOR TO A GENERATOR CHANGE FOR ELECTIVE REPLACEMENT INDICATOR (ERI), ALL LEAD IMPEDANCE VALUES WERE OUT OF RANGE, NO CAPTURE WAS OBSERVED ON ANY LEAD AND A BATTERY ADVISORY PERFORMANCE ALERT WAS NOTED TO HAVE BEEN TRIGGERED ON (B)(6) 2021. THE CHANGES IN IMPEDANCE AND CAPTURE WERE FOUND TO CORRESPOND WITH THE TIME OF THE BATTERY ALERT. THE DEVICE WAS EXPLANTED AND REPLACED. ALL LEAD CAPTURE AND IMPEDANCE VALUES WERE NORMAL FOLLOWING REPLACEMENT. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546145 ↗