Quadra AssuraRecalls & reported problems across all models
St. Jude Medical, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,811
- Deaths reported
- 77
- Injuries reported
- 1,125
- Recalls
- 0
We found 4 models of Quadra Assura by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 2,811 adverse event reports in the FDA's MAUDE database, received between Jul 5, 2016 and Jun 12, 2026 — classified as 77 deaths, 1,125 injuries, 1,609 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (1,144 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Quadra Assura problems
Device problems
- Over-Sensing1,144
- Battery Problem449
- Adverse Event Without Identified Device or Use Problem348
- Inappropriate or Unexpected Reset268
- Premature Discharge of Battery218
- Inappropriate/Inadequate Shock/Stimulation118
- Failure to Interrogate99
- Under-Sensing94
Patient problems
- No Known Impact Or Consequence To Patient1,548
- No Clinical Signs, Symptoms or Conditions643
- No Consequences Or Impact To Patient152
- Unspecified Infection114
- Therapeutic Effects, Unexpected87
- Death62
- Discomfort53
- Arrhythmia46
Quadra Assura models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quadra Assura™ CD3365-40QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Quadra Assura™ CD3265-40QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)12 deaths359 reports
- Quadra Assura™ CD3365-40CDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)9 deaths313 reports
- Quadra Assura™ CD3265-40Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)3 deaths83 reports
Recent Quadra Assura adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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