St Jude Medical Recalls Unify Cardiac Resynchronization Therapy Defibrillators
St Jude Medical is recalling specific Unify and Quadra Assura cardiac resynchronization therapy defibrillators because they may exhibit premature battery depletion.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The device may exhibit premature battery depletion."
Plain-English summary
St Jude Medical Inc. is recalling specific models of Unify, Unify Quadra, Unify Assura, Quadra Assura, and Quadra Assura MP cardiac resynchronization therapy defibrillators (CRTDs). The affected devices are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for the automated treatment of life-threatening ventricular arrhythmias, as well as bradycardia pacing and cardiac resynchronization therapy.
The recall is being issued because the devices may exhibit premature battery depletion. The source text does not specify the number of affected units, the distribution scope, or whether any injuries or illnesses have been reported.
Patients with these devices should contact their healthcare provider or St Jude Medical for instructions on how to proceed with the recall.
The recalled product
- Product
- Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model…
- Manufacturer
- St Jude Medical Inc.
- Hazard
- Affected units
- 89,109
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by St Jude Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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