Unify Assura™ CD3357-40CRecalls & 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 also paces the heart. Its 1,582 reports describe many cases of the device picking up electrical noise or the heart's own signals wrongly, and some mention unexpected resets, battery problems or unwanted shocks. The reports mention 56 deaths and 523 injuries. 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
- 1,588
- Deaths reported
- 56
- Injuries reported
- 526
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,588 adverse event reports that list this exact device (DI 05414734508186), received between Jun 10, 2018 and Sep 28, 2026 — classified as 56 deaths, 526 injuries, 1,006 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (757 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-Sensing757
- Adverse Event Without Identified Device or Use Problem274
- Inappropriate or Unexpected Reset121
- Battery Problem92
- Inappropriate/Inadequate Shock/Stimulation85
- Signal Artifact/Noise55
- Premature Discharge of Battery49
- Under-Sensing41
Patient problems
- No Known Impact Or Consequence To Patient573
- No Clinical Signs, Symptoms or Conditions567
- Unspecified Infection150
- No Consequences Or Impact To Patient69
- Pocket Erosion47
- Therapeutic Effects, Unexpected45
- Death44
- Insufficient Information44
Recent adverse event reports
The 25 most recent of 1,588 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Over-Sensing
It was reported that a patient's implantable cardioverter defibrillator (ICD) exhibited post-sensed T-wave oversensing. The ICD was explanted and replaced. The patient condition was not known.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916295 ↗InjurySep 15, 2026Failure to Deliver Shock/Stimulation; Incorrect Interpretation of Signal
Patient problems: Arrhythmia
MAUDE report 50782226 ↗MalfunctionSep 10, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724785 ↗MalfunctionSep 10, 2026Over-Sensing
Patient problems: Insufficient Information
MAUDE report 50715470 ↗MalfunctionSep 8, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676153 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented with infection, endocarditis and tricuspid valve vegetation. The physician explanted the active system ¿ implantable cardioverter defibrillator, right ventricular lead, left ventricular lead, right atrial lead ¿ and the three older inactive leads. A new leadless pacemaker was implanted. The patient was in stable condition.
Patient problems: Unspecified Infection
MAUDE report 50668745 ↗MalfunctionAug 31, 2026Over-Sensing
It was reported that a patient presented with over-sensing of noise noted on the patient's implantable cardioverter defibrillator. Pacing inhibition was noted. Further assessment was planned. No adverse patient consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533865 ↗MalfunctionAug 31, 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 50524832 ↗MalfunctionAug 19, 2026Failure to Deliver Shock/Stimulation; Under-Sensing
It was reported that the patient was admitted to the intensive care unit for cardiac arrest. It was found that the Implantable Cardioverter Defibrillator (ICD) exhibited undersensing which resulted in delayed treatment of arrythmia. It was determined that this undersensingfwas due to inappropriate programming settings and the device was reprogrammed. The patient was stable following changes.
Patient problems: Arrhythmia
MAUDE report 50314601 ↗MalfunctionAug 13, 2026Over-Sensing
Patient problems: Insufficient Information
MAUDE report 50244331 ↗MalfunctionAug 6, 2026Intermittent Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50168134 ↗MalfunctionJul 30, 2026Failure to Interrogate
It was reported that the patient was hospitalized in clinic with an oxygen mask and was not very conscious. The reason for the hospitalization and oxygen mask was unclear. It was noted that the Implantable Cardioverter Defibrillator (ICD) could not be interrogated with a programmer using a wand and there was no magnet response. Several attempts to interrogate the ICD were unsuccessful. The patient may have been pending an explant procedure, but this could not be conclusively confirmed by the patient's physician. There were no changes in patient condition or reported consequences.
Patient problems: Dyspnea
MAUDE report 50087370 ↗MalfunctionJul 6, 2026Over-Sensing
IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSING OF NOISE. THIS OVERSENSING RESULTED IN PACING INHIBITION. THE PRODUCT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25727565 ↗MalfunctionJun 29, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR FOLLOW UP. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING (PPTWOS). NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25654141 ↗MalfunctionJun 19, 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). PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE CHANGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565838 ↗MalfunctionJun 10, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING (PPTWOS). PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25460008 ↗MalfunctionJun 5, 2026Over-Sensing
IT WAS REPORTED THAT NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) DETERMINED TO BE MYOPOTENTIAL OVERSENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE RECOMMENDED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25417629 ↗InjuryJun 5, 2026Failure to Deliver Shock/Stimulation; Failure to Interrogate
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ARRHYTHMIA. UPON REVIEW, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FAILURE TO DELIVER SHOCK AND FAILURE TO INTERROGATE. NO INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: Arrhythmia
MAUDE report 25416345 ↗MalfunctionMay 27, 2026Failure to Capture; Therapy Delivered to Incorrect Body Area
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED BIVENTRICULAR LOSS OF CAPTURE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). ADDITIONALLY, THE PATIENT EXPERIENCED DISCOMFORT DUE TO PHRENIC NERVE STIMULATION. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: Discomfort
MAUDE report 25303418 ↗MalfunctionMay 21, 2026Over-Sensing; Pacing Problem; Pacing Asynchronously
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, COMPETITIVE ATRIAL PACING (CAP) AND INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS). PROGRAMMING CHANGES WERE SUGGESTED. NO INTERVENTION WAS PERFORMED AND THE PATIENT WILL BE FURTHER MONITORED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244609 ↗MalfunctionMay 11, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-SENSED T-WAVE OVERSENSING (PSTWOS). 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 25145276 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT PRESENTED WITH VALVE STENOSIS ALLEGED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2026. NO ADVERSE EFFECTS WERE NOTED.
Patient problems: Valvular Stenosis
MAUDE report 25142831 ↗DeathMay 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25081502 ↗InjuryApr 21, 2026Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCK. NO INTERVENTION WAS REPORTED. PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24947212 ↗InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO INFECTION AND EROSION AT THE DEVICE SITE. THE VEGETATION WAS NOTED ON THE RIGHT ATRIAL LEAD. THE PACEMAKER AND RIGHT ATRIAL LEAD WERE EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 24934961 ↗
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™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 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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