The Recall Desk
SevereFDA (Devices)·Z-0115-2017·Announced 2016-11-02

St Jude Medical Recalls Implantable Cardiac Defibrillators Due to Battery Defect

St Jude Medical is recalling specific implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because a lithium cluster in the battery can cause a short circuit and premature battery depletion.

What this means for you

Illness, injury, or structural failure has been reported. 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 rubric criteria for 'Severe' severity involving significant injury risk or structural defects in critical devices.

Plain-English summary

St Jude Medical Inc. is recalling specific models of Fortify, Fortify Assura, and Unify implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRTDs). The recall affects 204,785 units that were distributed worldwide, including nationwide in the United States and outside the U.S.

The devices are being recalled because they are subject to premature battery depletion. This issue is caused by a lithium cluster within the battery that can cause a short circuit. These devices are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for the automated treatment of life-threatening ventricular arrhythmias, and may also provide bradycardia pacing and cardiac resynchronization therapy.

Patients with these specific device models should contact their healthcare provider or St Jude Medical to determine if their device is affected and to discuss appropriate management options.

The recalled product

Product
Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C. Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-40, CD1363-40Q. Fortify DR, Model No. CD2231-40, CD2231-4
Manufacturer
St Jude Medical Inc.
Category
Medical Device — Implantable Cardiac Defibrillator
Hazard
Affected units
204,785

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 →

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Same hazard · battery depletion

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