Unify AssuraRecalls & reported problems across all models

We found 4 models of Unify Assura by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 3,532 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2018 and Sep 28, 2026 — classified as 116 deaths, 1,098 injuries, 2,318 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (1,765 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

Most reported Unify Assura problems

Unify Assura models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Unify Assura™ CD3357-40Q

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  54 deaths1,784 reports
• Unify Assura™ CD3357-40C

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  56 deaths1,588 reports
• Unify Assura™ CD3257-40

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 deaths108 reports
• Unify Assura™ CD3257-40Q

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths52 reports

Recent Unify Assura adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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

  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 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 ↗
• 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 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 26, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50464564 ↗

Other St. Jude Medical, Inc. products

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• Quartet10 models · 11,001 reports
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