St Jude Medical Recalls ICD and CRT-D Devices for Battery Short Circuit
St Jude Medical is recalling implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators due to a battery defect that can cause premature 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 recall involves a structural defect in a life-sustaining medical device (premature battery depletion due to short circuit) affecting a large number of units, which aligns with the criteria for a Severe rating involving significant injury risk or structural defects.
Plain-English summary
St Jude Medical is recalling specific models of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The affected devices include the Quadra Assura, Quadra Assura MP, Fortify, Fortify Assura, Unify, and Unify Assura models.
The recall is being issued because the devices are subject to premature battery depletion. This issue is caused by a lithium cluster within the battery that can create a short circuit. The devices are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for the automated treatment of life-threatening ventricular arrhythmias.
A total of 193,954 units are affected by this recall. The devices were distributed worldwide, including nationwide in the United States and in other countries. Patients with these devices should contact their healthcare provider or St Jude Medical for further instructions regarding the recall.
The recalled product
- Product
- 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…
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 193,954
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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