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.
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 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…
- Manufacturer
- St Jude Medical Inc.
- 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 →Related recalls
Same manufacturer · St Jude Medical Inc.
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Similar recalls
- SevereSt Jude Medical Recalls Fortify ICDs Due to Premature Battery Depletion
FDA (Devices) · 2017-10-18
- SevereSt Jude Medical Recalls Unify Cardiac Resynchronization Therapy Defibrillators
FDA (Devices) · 2017-10-18
- ModerateSt Jude Medical Recalls Fortify Assura ICDs for Security Firmware Update
FDA (Devices) · 2018-07-04
- SevereSt Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators
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- HighSt Jude Medical Recalls Fortify ICDs and CRT-Ds for Security Firmware Update
FDA (Devices) · 2018-07-04
- SevereSt Jude Medical Recalls Ellipse ICDs Due to High Voltage Capacitor Defect
FDA (Devices) · 2014-09-10