QUADRA ASSURA MPRecalls & 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
- 7,015
- Deaths reported
- 134
- Injuries reported
- 1,663
- Recalls
- 0
We found 4 models of QUADRA ASSURA MP by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 7,015 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2018 and Sep 30, 2026 — classified as 134 deaths, 1,663 injuries, 5,218 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (4,296 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 MP problems
Device problems
- Over-Sensing4,296
- Adverse Event Without Identified Device or Use Problem991
- Inappropriate or Unexpected Reset413
- Inappropriate/Inadequate Shock/Stimulation373
- Under-Sensing235
- Incorrect Interpretation of Signal182
- Pacing Problem177
- Signal Artifact/Noise164
Patient problems
- No Clinical Signs, Symptoms or Conditions3,171
- No Known Impact Or Consequence To Patient1,920
- Unspecified Infection686
- No Consequences Or Impact To Patient376
- Pocket Erosion176
- Arrhythmia156
- Discomfort156
- Therapeutic Effects, Unexpected149
QUADRA ASSURA MP models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- QUADRA ASSURA MP™ CD3369-40QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- QUADRA ASSURA MP™ CD3369-40CDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)31 deaths910 reports
- QUADRA ASSURA MP™ CD3269-40QDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)16 reports
- QUADRA ASSURA MP™ CD3269-40Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)5 reports
Recent QUADRA ASSURA MP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had bacteremia and their Implantable Cardioverter Defibrillator (ICD), right ventricular (RV) lead, right atrial (RA) lead, and left ventricular (LV) lead were explanted as a result. The patient was stable.
Patient problems: Unspecified Infection
MAUDE report 50951648 ↗MalfunctionSep 28, 2026Failure to Capture
It was reported that a patient presented remotely via Merlin.net. Review of the transmission revealed that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited loss of capture stored as Non-Sustained Right Ventricular Oversensing (NSRVO) episodes. Programming changes were discussed, no changes or interventions were reported. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916103 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented to the clinic for a follow-up visit with pocket infection and device erosion. It was noted that the implantable cardioverter-defibrillator (ICD) had eroded through the skin, with an opening in the skin near the device and associated redness. The physician does not believe infection was device or procedure related. The entire system, including the ICD, right ventricular lead, right atrial lead, and left ventricular lead was explanted. The patient remained in a stable condition.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 50910888 ↗InjurySep 19, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831630 ↗MalfunctionSep 18, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831605 ↗InjurySep 18, 2026Pacing Problem; Pacing Asynchronously; No Apparent Adverse Event
New information received indicates that the Implantable Cardioverter Defibrillator (ICD) was explanted due to Elective Replacement Indicator (ERI).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831091 ↗MalfunctionSep 18, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830865 ↗MalfunctionSep 16, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796985 ↗MalfunctionSep 11, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736875 ↗MalfunctionSep 10, 2026Over-Sensing
It was reported that the patient presented remotely via Merlin.net. Review of the transmission revealed that the implantable cardioverter defibrillator exhibited myopotential oversensing. Further information was requested however, was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719390 ↗MalfunctionSep 10, 2026Intermittent Capture
It was reported that the Implantable Cardioverter Defibrillator (ICD) exhibited intermittent ventricular capture. No intervention was reported. There were no patient symptoms reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718053 ↗MalfunctionSep 9, 2026Over-Sensing
It was reported during remote follow up that the Implantable Cardioverter Defibrillator (ICD) exhibited Post-Paced T-wave Oversensing (PPTWOS). The device was reprogrammed. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695419 ↗MalfunctionSep 7, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658550 ↗MalfunctionSep 4, 2026Failure to Interrogate; Compatibility Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50620601 ↗MalfunctionSep 4, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50620450 ↗
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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