Fortify Assura™ CD2357-40QRecalls & reported problems
St. Jude Medical, Inc. · Tiered-therapy cardioverter/defibrillator VVEV VVIR · Class 3 · Implant
All models of Fortify Assura (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Fortify Assura is an implanted heart defibrillator that delivers shocks to correct irregular heart rhythms. Many reports describe the device misreading heart signals, battery problems, and shocks at the wrong time or unexpected resets. The 3,564 reports include 63 deaths and 1,646 injuries. No recalls name this device. Reports fell to 99 in the last 12 months from 182 in the previous 12 months.
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
- 3,571
- Deaths reported
- 63
- Injuries reported
- 1,649
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,571 adverse event reports that list this exact device (DI 05414734508094), received between Jun 11, 2018 and Sep 30, 2026 — classified as 63 deaths, 1,649 injuries, 1,859 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (1,236 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-Sensing1,236
- Adverse Event Without Identified Device or Use Problem446
- Battery Problem446
- Premature Discharge of Battery391
- Inappropriate/Inadequate Shock/Stimulation353
- Inappropriate or Unexpected Reset260
- Incorrect Interpretation of Signal203
- Under-Sensing192
Patient problems
- No Clinical Signs, Symptoms or Conditions1,478
- No Known Impact Or Consequence To Patient1,140
- Unspecified Infection292
- No Consequences Or Impact To Patient146
- Therapeutic Effects, Unexpected140
- Insufficient Information110
- Discomfort101
- Arrhythmia98
Recent adverse event reports
The 25 most recent of 3,571 reports, 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 ↗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 9, 2026Failure to Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697712 ↗InjurySep 4, 2026Inappropriate/Inadequate Shock/Stimulation; Under-Sensing
It was reported that the patient received an inappropriate shock by the Implantable Cardioverter Defibrillator (ICD) due to under sensing of atrial fibrillation. Programming changes were completed. The patient was stable before, during and after the programming changes. The patient was stable before, during and after the programming changes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50618748 ↗InjurySep 4, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
It was reported that the patient had previously complained of discomfort due to Inappropriate Shocks. It was noted that several rounds of inappropriate antitachycardia pacing therapy (ATP) due to atrial activity falling in the blanking period were observed on the Implantable Cardioverter Defibrillator (ICD). Programing recommendations were passed on to the physician who recommended some additional changes. The patient was pending follow up in clinic for changes to be made. There were no other reported patient consequences.
Patient problems: Discomfort
MAUDE report 50615990 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Discomfort
MAUDE report 50576772 ↗MalfunctionSep 2, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576454 ↗InjurySep 1, 2026Inappropriate/Inadequate Shock/Stimulation
It was reported that the implantable cardioverter defibrillator exhibited inappropriate shock. Programming changes were performed. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50553615 ↗MalfunctionAug 24, 2026Failure to Convert Rhythm
It was reported that a patient presented remotely via (b)(6). Review of the transmission revealed that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited inadequate Anti-Tachycardia Pacing (ATP) which failed to convert the Ventricular Tachycardia (VT), and the patient was still in VT. Programming changes were discussed, no changes or interventions were reported. There were no patient consequences.
Patient problems: Arrhythmia
MAUDE report 50410548 ↗MalfunctionAug 21, 2026Interrogation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50373508 ↗InjuryAug 20, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
It was reported that the patient presented in the clinic. It was noted that the Implantable Cardioverter Defibrillator (ICD) delivered inappropriate shock due to incorrect interpretation of supraventricular tachycardia (SVT). Programming changes were made. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50360026 ↗MalfunctionAug 18, 2026Over-Sensing
It was reported that the implantable cardioverter defibrillator exhibited post-paced t-wave oversensing. No intervention was performed. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50292539 ↗MalfunctionAug 17, 2026Over-Sensing
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited oversensing. No intervention was performed and the patient's status was unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50286833 ↗InjuryAug 13, 2026Inappropriate/Inadequate Shock/Stimulation; Under-Sensing
It was reported that the patient's implantable cardioverter-defibrillator (ICD) delivered an inappropriate shock due to functional under-sensing, where the atrial events fell within the post-ventricular atrial blanking (PVAB) period. The physician restarted the patient's medications. The patient's condition remained stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50244137 ↗MalfunctionAug 10, 2026Under-Sensing
It was reported that remote transmissions noting atrial under sensing were observed across ventricular tachycardia (VT) episodes. Programming changes were suggested. There were no reported patient consequences.
Patient problems: Insufficient Information
MAUDE report 50199231 ↗MalfunctionAug 10, 2026Over-Sensing
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited oversensing during a capacitor maintenance charge, which was stored as Non-Sustained Right Ventricular Oversensing (NSRVO) episodes. No intervention was performed, and the patient would continue to be monitored. The patient's condition remained stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50196337 ↗MalfunctionAug 7, 2026Inappropriate or Unexpected Reset
It was reported that a patient presented remotely via Merlin.net. Review of the transmission revealed that the patient's Implantable Cardioverter Defibrillator (ICD) was operating in the backup operation. 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 50178011 ↗InjuryAug 6, 2026Signal Artifact/Noise; Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
It was reported that the patient experienced a ventricular tachycardia (VT) episode and presented to the emergency room. Upon examination, it was observed that the Implantable Cardioverter Defibrillator (ICD) did not deliver shock therapy because the patient's VT episode is slower than the programmed settings for high voltage therapy. The device detection and therapy was reprogrammed. Further review showed that the ICD had noise on the atrial channel and inappropriate anti-tachycardia pacing (ATP) and shock were delivered. No intervention was performed for the noise anomaly and subsequent shock as the patient is being hospitalized for a scheduled VT ablation procedure. The patient's condition was stable.
Patient problems: Arrhythmia
MAUDE report 50168264 ↗MalfunctionAug 6, 2026Inappropriate or Unexpected Reset; Compatibility Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50159908 ↗MalfunctionAug 5, 2026Failure to Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50148001 ↗InjuryJul 29, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
It was reported that the device delivered inappropriate shock due to atrial fibrillation with rapid ventricular response. The event was resolved by rate control. The patient was stable.
Patient problems: Insufficient Information
MAUDE report 50075534 ↗
Other Pulse generator, permanent, implantable devices
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- Advisa DR MRI™ SureScan® A2DR01Medtronic, Inc. · Pulse generator, permanent, implantable51 deaths2,298 reports
- Fortify Assura™ CD1357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable35 deaths1,933 reports
- Ellipse™ CD2411-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable42 deaths1,498 reports
- Fortify Assura™ CD2357-40CSt. Jude Medical, Inc. · Pulse generator, permanent, implantable25 deaths1,378 reports
- Accent® DR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable73 deaths1,370 reports
- Edora 8 DR-T 407145BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable10 deaths982 reports
- Zephyr™ XL DRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable24 deaths944 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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