Fortify AssuraRecalls & reported problems across all models
St. Jude Medical, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8,292
- Deaths reported
- 154
- Injuries reported
- 4,512
- Recalls
- 0
We found 8 models of Fortify Assura by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 8,292 adverse event reports in the FDA's MAUDE database, received between Feb 26, 2018 and Sep 30, 2026 — classified as 154 deaths, 4,512 injuries, 3,626 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (2,032 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 Fortify Assura problems
Device problems
- Over-Sensing2,032
- Battery Problem1,515
- Premature Discharge of Battery1,400
- Adverse Event Without Identified Device or Use Problem1,011
- Inappropriate/Inadequate Shock/Stimulation704
- Inappropriate or Unexpected Reset662
- Incorrect Interpretation of Signal396
- Failure to Interrogate371
Patient problems
- No Clinical Signs, Symptoms or Conditions3,276
- No Known Impact Or Consequence To Patient2,948
- Unspecified Infection589
- No Consequences Or Impact To Patient327
- Insufficient Information308
- Therapeutic Effects, Unexpected300
- Arrhythmia218
- Discomfort200
Fortify Assura models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Fortify Assura™ CD2357-40QPulse generator, permanent, implantable63 deaths3,571 reports
- Fortify Assura™ CD1357-40QPulse generator, permanent, implantable35 deaths1,933 reports
- Fortify Assura™ CD2357-40CPulse generator, permanent, implantable25 deaths1,378 reports
- Fortify Assura™ CD1357-40CPulse generator, permanent, implantable18 deaths615 reports
- Fortify Assura™ CD2257-40QPulse generator, permanent, implantable4 deaths269 reports
- Fortify Assura™ CD1257-40QPulse generator, permanent, implantable4 deaths250 reports
- Fortify Assura™ CD2257-40Pulse generator, permanent, implantable3 deaths190 reports
- Fortify Assura™ CD1257-40Pulse generator, permanent, implantable2 deaths86 reports
Recent Fortify Assura adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Inappropriate or Unexpected Reset
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) inappropriately went into backup operation with high voltage therapies disabled. The ICD was explanted. The patient's condition was unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949089 ↗MalfunctionSep 30, 2026Over-Sensing
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited Far R wave oversensing. Additional information was requested and not received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949027 ↗MalfunctionSep 26, 2026Over-Sensing
Patient problems: Insufficient Information
MAUDE report 50906544 ↗InjurySep 24, 2026Failure to Convert Rhythm
It was discovered via remote transmission that the Implantable Cardioverter Defibrillator (ICD) exhibited a failure to convert patient arrythmia due to unacceptable defibrillation threshold. The patient was externally defibrillated. The patient was stable.
Patient problems: Arrhythmia
MAUDE report 50885585 ↗MalfunctionSep 24, 2026Over-Sensing
It was reported that the device exhibited post-paced T-wave oversensing (PPTWOS). Programming changes were made. No further PPTWOS were seen. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885324 ↗MalfunctionSep 18, 2026Signal Artifact/Noise
Patient problems: Insufficient Information
MAUDE report 50831141 ↗MalfunctionSep 18, 2026Over-Sensing; Pacing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827939 ↗MalfunctionSep 18, 2026Inappropriate or Unexpected Reset
It was reported that the Implantable Cardioverter Defibrillator (ICD) had gone into backup mode. No intervention was reported and patient condition was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823752 ↗InjurySep 16, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing
It was reported that the device delivered an inappropriate therapy due to incorrect interpretation of signal caused by intermittent atrial undersensing. No intervention was performed, and no patient symptoms were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790187 ↗MalfunctionSep 10, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722318 ↗DeathSep 10, 2026Failure to Convert Rhythm; Low impedance
It was reported that the right ventricular (RV) lead's high voltage (HV) impedance was observed to be low via remote monitoring. The patient was noted to be in ventricular fibrillation (VF) and the Implantable Cardioverter Defibrillator (ICD) attempted to shock. On the third attempt the patient did convert successfully in the right ventricular (RV) to Superior Vena Cava (SVC) shocking vector. The patient was in and out of VF since 1:00 PM that day and the observation was made at 11:50 PM. A transmission at 2:00 AM noted a normal rhythm. The clinician contacted the patient, and it was noted that the patient had passed away in the middle of the night.
Patient problems: Arrhythmia
MAUDE report 50704857 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented to the hospital with pain at the device pocket. It was also noted that the patient's implantable cardioverter defibrillator (ICD) had eroded through the skin. The ICD was explanted. A new ICD system was implanted. The patient had no adverse consequences.
Patient problems: Discomfort; Pocket Erosion
MAUDE report 50703807 ↗MalfunctionSep 9, 2026Failure to Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697712 ↗MalfunctionSep 8, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680134 ↗InjurySep 4, 2026Premature Discharge of Battery; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50622748 ↗
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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