St Jude Medical Recalls Fortify ICDs Due to Premature Battery Depletion
St Jude Medical is recalling approximately 90,563 Fortify and Fortify Assura implantable cardioverter defibrillators because they may exhibit premature battery depletion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a life-sustaining medical device (ICD) with a functional defect (premature battery depletion) that poses a risk of harm, but the source text does not report any specific injuries, deaths, or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
St Jude Medical Inc. is recalling specific models of Fortify and Fortify Assura implantable cardioverter defibrillators (ICDs). The affected devices include the Fortify VR, Fortify ST VR, Fortify Assura VR, Fortify Assura ST VR, Fortify DR, Fortify ST DR, Fortify Assura DR, and Fortify Assura ST VR series. The recall covers approximately 90,563 units distributed nationwide in the United States.
The recall is being issued because the devices may exhibit premature battery depletion. These ICDs are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for the automated treatment of life-threatening ventricular arrhythmias, and may also be programmed to provide single or dual chamber bradycardia pacing.
Patients with these specific device models should contact their healthcare provider to discuss the recall and determine the appropriate course of action. The source text does not specify a particular deadline or immediate emergency action beyond contacting a provider.
The recalled product
- Product
- Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Forti
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 90,563
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
Same manufacturer · St Jude Medical Inc.
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- SevereSt Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators
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