Quadra Assura™ CD3365-40QRecalls & 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 Quadra Assura defibrillator is an implanted device that paces the heart and delivers shocks to correct irregular heart rhythms. Its 2,057 adverse event reports mostly describe the device reading extra signals as heartbeats, battery problems and unexpected resets, and some mention inappropriate shocks. The reports include 53 deaths and 784 injuries. Reports in the last 12 months number 11, down from 26 in the previous 12 months. 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
- 2,056
- Deaths reported
- 53
- Injuries reported
- 783
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,056 adverse event reports that list this exact device (DI 05414734508292), received between Jan 4, 2017 and Jun 12, 2026 — classified as 53 deaths, 783 injuries, 1,220 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (853 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-Sensing853
- Battery Problem317
- Adverse Event Without Identified Device or Use Problem234
- Inappropriate or Unexpected Reset212
- Premature Discharge of Battery159
- Inappropriate/Inadequate Shock/Stimulation86
- Failure to Interrogate71
- Under-Sensing70
Patient problems
- No Known Impact Or Consequence To Patient1,072
- No Clinical Signs, Symptoms or Conditions530
- No Consequences Or Impact To Patient113
- Unspecified Infection87
- Therapeutic Effects, Unexpected56
- Discomfort42
- Death41
- Arrhythmia40
Recent adverse event reports
The 25 most recent of 2,056 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Over-Sensing; Pacing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED EPISODES OF FAR R OVER-SENSING AND INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS). THE ICD WAS REPROGRAMMED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25490155 ↗MalfunctionJun 9, 2026Over-Sensing
IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING (PPTWOS). THE PRODUCT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25452155 ↗MalfunctionMay 13, 2026Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WENT INTO BACKUP OPERATION. NO INTERVENTION WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THE PATIENT'S CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164182 ↗MalfunctionMay 12, 2026Over-Sensing
IT WAS REPORTED THAT POST-PACED T-WAVE OVERSENSING (PPTWOS) WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149780 ↗MalfunctionApr 14, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE. THE PATIENT HAD NO ADVERSE CONSEQUENCES DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24876432 ↗MalfunctionApr 14, 2026Over-Sensing
IT WAS REPORTED THAT POST PACED T WAVE OVERSENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24868007 ↗InjuryMar 23, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING. THE ICD WAS EXPLANTED AND REPLACED. THE PATIENT'S CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663370 ↗MalfunctionMar 9, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FAR R-WAVE OVERSENSING. NO INTERVENTION WAS PERFORMED, AND THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24550486 ↗MalfunctionFeb 5, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCK DUE TO INCORRECT INTERPRETATION OF SIGNAL. INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) POTENTIALLY INDUCED ACTUAL VENTRICULAR TACHYCARDIA (VT) WHICH WAS SUCCESSFULLY RESOLVED BY THE DEVICE. THE PRODUCT WILL CONTINUE TO BE MONITORED. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Arrhythmia
MAUDE report 24273099 ↗MalfunctionFeb 2, 2026Over-Sensing
IT WAS REPORTED THAT NON SUSTAINED OVERSENSING DETERMINED TO BE FAR P WAVE OVERSENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE RECOMMENDED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24238762 ↗InjuryOct 24, 2025Over-Sensing; Over-Sensing
NEW INFORMATION NOTED THAT AN ICD WAS EXPLANTED AND REPLACED WITH NEW ICD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379125 ↗MalfunctionSep 19, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. A DEVICE INTERROGATION WAS PERFORMED AND REVEALED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097760 ↗InjurySep 11, 2025Delayed Charge Time; Delayed Charge Time
NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI)/ END OF LIFE (EOL). THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23032995 ↗InjuryAug 21, 2025No Pacing; No Pacing
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC DUE TO SYMPTOMS OF SYNCOPE AND CHEST PAIN DUE TO LOSS OF PACING, THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS EXPLANTED AND REPLACED ON (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Discomfort; Syncope/Fainting
MAUDE report 22863485 ↗MalfunctionAug 19, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT POST PACED T WAVE OVERSENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE RECOMMENDED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22846510 ↗MalfunctionAug 6, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT POST-PACED T-WAVE OVERSENSING (PPTWOS) WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22734109 ↗DeathJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN INFECTION NOTED ON THE SYSTEM. IT WAS THEN NOTED THAT THE PATIENT DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INTERVENTION WAS REPORTED. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 22503401 ↗MalfunctionJun 18, 2025Therapy Delivered to Incorrect Body Area; Environmental Compatibility Problem; Inappropriate or Unexpected Reset; Therapy Delivered to Incorrect Body Area; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC, THE PATIENT HAD EXPERIENCED DISCOMFORT AND STIMULATION. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPERIENCING BACK UP VVI WITH NO BACKUP DEFIBRILLATION THERAPY OBSERVED DUE TO A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE THAT HAD BEEN PERFORMED WITHOUT A MODE CHANGE. THE ISSUE WAS RESOLVED BY PERFORMING A DEVICE DOWNLOAD. THE PATIENT WAS STABLE.
Patient problems: Discomfort
MAUDE report 22286215 ↗MalfunctionMay 7, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED POST-PACED T-WAVE OVERSENSING (PPTWOS) ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO CHANGES OR INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21977556 ↗InjuryMay 5, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT NOISE OVERSENSING, INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS), AND LOW PACING IMPEDANCE WERE NOTED ON THE PATIENT'S RIGHT ATRIAL (RA) LEAD. ADDITIONALLY, T-WAVE OVERSENSING WAS NOTED ON THE ICD. ON (B)(6) 2025, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RA LEAD. THE ICD WAS ALSO EXPLANTED AND REPLACED DURING THE SAME PROCEDURE. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21961458 ↗MalfunctionApr 22, 2025Interrogation Problem; Interrogation Problem
IT WAS REPORTED THAT A LACK OF RADIO FREQUENCY (RF) TELEMETRY COMMUNICATION WAS OBSERVED BETWEEN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND PROGRAMMER. A CYBERSECURITY FIRMWARE UPDATE WAS PERFORMED, AND THE ISSUE WAS RESOLVED. THERE WERE NO REPORTED PATIENT SYMPTOMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21883836 ↗MalfunctionApr 18, 2025Over-Sensing; Over-Sensing
NEW INFORMATION RECEIVED NOTES NO PROGRAMMING CHANGES WERE MADE, THE LAST REMOTE MONITORING CHECK UP ON (B)(6) 2025, DID NOT SHOW ANY OVERSENSING EPISODES. THE PATIENT WAS BEING MONITORED. THERE WERE NO CHANGES IN PATIENT CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21869166 ↗InjuryApr 1, 2025Premature Discharge of Battery; Premature Discharge of Battery
THIS REPORT IS RELATED TO PREVIOUSLY REPORTED COMPLAINT OF PREMATURE BATTERY DEPLETION, REPORTED ON ((B)(6) 2016), MFR NUMBER 2938836-2016-01047.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21736721 ↗MalfunctionMar 27, 2025Over-Sensing; Over-Sensing
IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST PACED T WAVE OVERSENSING. IT WAS ALSO NOTED THAT PATIENT EXPERIENCED ARRHYTHMIA. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.
Patient problems: Arrhythmia
MAUDE report 21710171 ↗MalfunctionMar 27, 2025Therapy Delivered to Incorrect Body Area; Inappropriate or Unexpected Reset; Therapy Delivered to Incorrect Body Area; Inappropriate or Unexpected Reset
NEW INFORMATION NOTED THAT PATIENT PRESENTED IN AN EMERGENCY ROOM EXPERIENCING DIAPHRAGMATIC STIMULATION AND IT WAS NOTED THAT DEVICE WENT INTO BACK UP MODE. HIGH VOLTAGE THERAPIES WERE ACTIVE AT THE TIME OF BACKUP MODE. PROGRAMMING CHANGES WERE MADE TO RESTORE THE ORIGINAL MODE. PATIENT CONDITION WAS STABLE.
Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions
MAUDE report 21708312 ↗
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
- 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
- Claria MRI™ Quad CRT-D SureScan™ DTMA1QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)22 deaths1,479 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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