Unify Assura™ CD3357-40QRecalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV · Class 3 · Implant
All models of Unify Assura (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Unify Assura is an implanted defibrillator that paces the heart and delivers shocks. Of its 1,781 reports, many describe the device reading electrical noise as heartbeats, unexpected resets, and inappropriate or inadequate shocks. The reports include 55 deaths and 506 injuries, and some mention infection and pocket erosion. Reports fell from 140 in the prior 12 months to 79 in the latest 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
- 1,784
- Deaths reported
- 54
- Injuries reported
- 506
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,784 adverse event reports that list this exact device (DI 05414734508216), received between Jun 11, 2018 and Sep 18, 2026 — classified as 54 deaths, 506 injuries, 1,224 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (956 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-Sensing956
- Adverse Event Without Identified Device or Use Problem284
- Inappropriate or Unexpected Reset110
- Inappropriate/Inadequate Shock/Stimulation85
- Under-Sensing79
- Battery Problem59
- Signal Artifact/Noise46
- Pacing Problem44
Patient problems
- No Clinical Signs, Symptoms or Conditions784
- No Known Impact Or Consequence To Patient515
- Unspecified Infection182
- No Consequences Or Impact To Patient68
- Pocket Erosion58
- Discomfort48
- Arrhythmia42
- Insufficient Information42
Recent adverse event reports
The 25 most recent of 1,784 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Over-Sensing; Pacing Problem; Environmental Compatibility Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831355 ↗InjurySep 18, 2026Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829662 ↗MalfunctionSep 17, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812667 ↗MalfunctionSep 10, 2026Over-Sensing
It was reported that the patient presented remotely. A remote transmission showed that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited Post-Paced T-wave Oversensing. No intervention was performed. The patient had no adverse consequences due to the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717720 ↗MalfunctionSep 2, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555483 ↗MalfunctionSep 1, 2026Under-Sensing
It was reported that the patient presented remotely via merlin.net. Review of transmission revealed that the Implantable Cardioverter Defibrillator (ICD) exhibited under-sensing. No intervention was performed. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549255 ↗MalfunctionAug 26, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50464564 ↗MalfunctionAug 25, 2026Failure to Charge
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50442442 ↗MalfunctionAug 21, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382920 ↗MalfunctionAug 20, 2026Under-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50359498 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented in the emergency room due to pocket erosion. The physician explanted the entire implantable cardioverter-defibrillator system to resolve the issue. The patient's status was unknown.
Patient problems: Pocket Erosion
MAUDE report 50336113 ↗MalfunctionAug 14, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260278 ↗MalfunctionAug 12, 2026Over-Sensing
Patient problems: Insufficient Information
MAUDE report 50227587 ↗MalfunctionAug 6, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161559 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented with a bacteremia infection. The implantable cardioverter defibrillator (ICD), right ventricular lead, and left ventricular lead were explanted. The patient was reported to be recovering following the procedure.
Patient problems: Unspecified Infection
MAUDE report 50137445 ↗MalfunctionJul 9, 2026Pacing Asynchronously; Sensing Intermittently
IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INTERMITTENT SENSING DUE TO PSEUDO-FUSION. THE PRODUCT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25772021 ↗InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM DUE TO INFECTION. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 25555999 ↗MalfunctionJun 18, 2026Difficult to Remove
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A STANDARD GENERATOR CHANGEOUT PROCEDURE. DURING THE PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)'S SET SCREW WAS DIFFICULT TO REMOVE. IT WAS EVENTUALLY LOOSENED, AND THE ICD WAS SUCCESSFULLY REPLACED. THE PATIENT REMAINED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25555370 ↗MalfunctionJun 18, 2026Over-Sensing
IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING (PPTWOS). PROGRAMMING CHANGES WERE SUCCESSFULLY IMPLEMENTED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25549542 ↗MalfunctionJun 17, 2026Failure to Capture
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A LOSS OF CAPTURE. NO INTERVENTION WAS PERFORMED, AND THE PATIENT'S STATUS WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25539958 ↗MalfunctionJun 12, 2026Under-Sensing
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ATRIAL UNDER-SENSING. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488090 ↗DeathJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO SYSTOLIC HEART FAILURE, VENTRICULAR TACHYCARDIA, AND ACUTE HYPOXIC RESPIRATORY FAILURE. THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL (RA) LEAD, AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446600 ↗MalfunctionJun 5, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC DUE TO SYMPTOMS OF DIZZINESS. A DEVICE INTERROGATION SHOWED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: Dizziness
MAUDE report 25411829 ↗InjuryMay 29, 2026Failure to Deliver Shock/Stimulation
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAILED TO DELIVER SHOCK. FURTHER INFORMATION WAS REQUESTED; HOWEVER, WAS NOT PROVIDED.
Patient problems: Arrhythmia
MAUDE report 25340380 ↗MalfunctionMay 27, 2026Over-Sensing
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT POST PACED T WAVE OVERSENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25307908 ↗
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
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 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™ CD3357-40CSt. 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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