Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Quadra Assura Recalled by St Jude Medical Inc. Due to St Jude Medical is recalling implantable cardiac defibrillator...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact St Jude Medical Inc. directly.
Affected Products
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
Quantity: 193,954 units
Why Was This Recalled?
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About St Jude Medical Inc.
St Jude Medical Inc. has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report