Quadra Assura™ CD3365-40CRecalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV · Class 3 · Implant
All models of Quadra Assura (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Quadra Assura is a combined pacemaker and defibrillator implanted to treat abnormal heart rhythms. Many of the 313 reports describe the device misreading heart signals, and some describe batteries running down early. There were 140 injury reports and 9 deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 313
- Deaths reported
- 9
- Injuries reported
- 140
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 313 adverse event reports that list this exact device (DI 05414734508261), received between Jul 5, 2016 and Feb 3, 2025 — classified as 9 deaths, 140 injuries, 164 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (117 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.
Reports received per month
Most reported problems
Device problems
- Over-Sensing117
- Adverse Event Without Identified Device or Use Problem46
- Battery Problem40
- Premature Discharge of Battery30
- Inappropriate or Unexpected Reset29
- Under-Sensing18
- Inappropriate/Inadequate Shock/Stimulation17
- Failure to Interrogate13
Patient problems
- No Known Impact Or Consequence To Patient163
- No Clinical Signs, Symptoms or Conditions68
- Unspecified Infection16
- Therapeutic Effects, Unexpected15
- No Consequences Or Impact To Patient14
- Death8
- Arrhythmia6
- Pocket Erosion6
Recent adverse event reports
The 25 most recent of 313 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN NET IT WAS NOTED THAT INAPPROPRIATE AUTO MODE SWITCHING (AMS) AND INTERMITTENT FAR FIELD R WAVE OVERSENSING RESULTING FROM BIGEMINAL PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WERE OBSERVED FOLLOWING THE BIVENTRICULAR PACING. CONTINUED MONITORING SINCE THE RHYTHM WAS ATYPICAL OR PROGRAMMING CHANGES WERE RECOMMENDED. THERE WERE NO REPORTED PATIENT SYMPTOMS OR CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21300501 ↗InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD POCKET INFECTION AND EROSION. THE ENTIRE IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 19969990 ↗MalfunctionApr 24, 2024Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem
IT WAS REPORTED THAT THE DEVICE EXHIBITED INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS) EPISODES DUE TO FAR R OVER-SENSING ON THE ATRIAL CHANNEL. PROGRAMMING CHANGES WERE DISCUSSED BUT NOT MADE AT THIS TIME. THE PATIENT WAS ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19173249 ↗InjuryApr 3, 2024Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC. DEVICE INTERROGATION REVEALED PREMATURE BATTERY DEPLETION ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19032436 ↗MalfunctionFeb 20, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON REVIEW, IT WAS DISCOVERED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND TO BE IN BACKUP OPERATION. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18744358 ↗InjuryJan 10, 2024Over-Sensing; Over-Sensing
NEW INFORMATION NOTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND NEW ICD WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18489647 ↗MalfunctionDec 28, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) DUE TO POST-PACED T-WAVE OVERSENSING (PPTWOS). THE PATIENT DID NOT RECEIVE THERAPY DURING THE OVERSENSING. THE DEVICE WAS REPROGRAMMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18414684 ↗MalfunctionNov 21, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. INTERROGATION OF TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED FAR P WAVE OVERSENSING. NO INTERVENTIONS WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18187456 ↗MalfunctionNov 19, 2023Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS FOUND IN BACKUP MODE DUE TO MAGNETIC RESONANCE IMAGING (MRI) PERFORMED IN AN OFF LABEL ENVIRONMENT. PROGRAMMING CHANGES WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18167322 ↗MalfunctionOct 11, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T-WAVE OVERSENSING. FURTHER INFORMATION WAS REQUESTED HOWEVER WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17917231 ↗MalfunctionAug 23, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T-WAVE OVERSENSING. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17608592 ↗MalfunctionJul 31, 2023Under-Sensing; Under-Sensing
IT WAS REPORTED THAT UNDERSENSING OF VARYING SMALLER R WAVES WAS OBSERVED IN NON SUSTAINED EPISODES ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT WAS BROUGHT INTO CLINIC AND PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS DISCHARGED AND WAS TO CONTINUE BEING MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17430784 ↗MalfunctionMay 3, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED FOR A PERIOD OF ONE-HOUR, EPISODES OF POST-PACED T-WAVE OVERSENSING. THE PATIENT WILL FURTHER BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16861171 ↗MalfunctionMar 31, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED WITH OVER-SENSING NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. NO INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16659326 ↗MalfunctionMar 28, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED REMOTELY VIA MERLIN.NET ON (B)(6)2023. REVIEW OF THE TRANSMISSION REVEALED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS POST PACED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL. THE PATIENT DID NOT RECEIVE ANY THERAPY DURING THE OVERSENSING. THE PROGRAMMING CHANGES WERE RECOMMENDED BUT WERE NOT PERFORMED AT THIS TIME. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16633009 ↗MalfunctionMar 13, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST PACED T-WAVE OVERSENSING. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16534983 ↗MalfunctionMar 3, 2023Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T-WAVE OVERSENSING. THE DEVICE WAS REPROGRAMMED. THE PATIENT CONDITION WAS UNKNOWN POST-INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16479545 ↗DeathJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER:2017865-2023-04555, RELATED MANUFACTURER REFERENCE NUMBER:2017865-2023-04557, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-04558. IT WAS REPORTED THAT THE PATIENT DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16269661 ↗InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE DEVICE IS SUBJECT TO THE ASSURITY AND ENDURITY PACEMAKERS HEADER ANOMALY ADVISORY ISSUED BY ABBOTT ON 15 MARCH 2021. THE PACEMAKER WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16153354 ↗InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-00069; RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-00071. IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL WITH SEPTIC SHOCK DUE TO BACTEREMIA. UPON EXAMINATION, THE RIGHT ATRIAL (RA) LEAD WAS DISCOVERED TO HAVE VEGETATION. THE ENTIRE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: Unspecified Infection
MAUDE report 16084386 ↗InjuryDec 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC DUE TO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET EROSION. THE ICD WAS EXPLANTED DUE TO EROSION. THE PATIENT'S CONDITION WAS STABLE.
Patient problems: Pocket Erosion
MAUDE report 16041163 ↗InjuryDec 13, 2022Over-Sensing; Over-Sensing
NEW INFORMATION RECEIVED NOTES THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED IN A PROCEDURE ON (B)(6) 2023. THE PATIENT STATUS WAS UNKNOWN.
Patient problems: Arrhythmia
MAUDE report 15970760 ↗MalfunctionDec 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED ELECTROGRAM ANOMALY; A MORPHOLOGY TEMPLATE ELECTROGRAM WAS RECORDED ON A DEVICE WHERE THE MORPHOLOGY TEMPLATE DISCRIMINATOR AND CONSEQUENTLY THE EPISODE TRIGGER WAS TURNED OFF. NO INTERVENTION WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15892988 ↗InjuryNov 7, 2022Premature Discharge of Battery; Failure to Charge; Premature Discharge of Battery; Failure to Charge
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REMOTE FOLLOW-UP VIA MERLIN.NET WITH THE ELECTIVE REPLACEMENT INDICATOR (ERI) ALERT ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. PRIOR TO THE GENERATOR CHANGE, A DEVICE INTERROGATION INDICATED ALERTS TRIGGERED FOR END OF SERVICE (EOS), CAPACITOR CHARGE TIME OUT, AND BATTERY PERFORMANCE ALERT (BPA). ALTHOUGH THE PATIENT WAS NOT PACING-DEPENDENT, THE DEVICE WAS URGENTLY EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15749703 ↗MalfunctionOct 11, 2022Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS OVER-SENSING NOISE. THE NOISE WAS SUSPECTED TO BE CAUSED BY A DEVICE DIAGNOSTIC CHECK. NO INTERVENTION WAS PERFORMED. THE PATIENT WILL FURTHER BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15580670 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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