Agency classClass IOur severity:Severe FDA (Devices)·Z-0003-2018·Announced 2017-10-18

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.

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 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…
Manufacturer: St Jude Medical Inc.
Category: Medical Device — Implantable Cardioverter Defibrillator
Hazard: battery-depletion
device-failure
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 →

Same manufacturer · St Jude Medical Inc.

See all →

Severe
St Jude Medical Recalls 15 Ellipse DR Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
Severe
St Jude Medical Recalls 42 Ellipse DR Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
Severe
St Jude Medical Recalls 47 Ellipse VR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
Severe
St Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
Severe
St Jude Medical Recalls 21 Ellipse DR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14

Same hazard · battery depletion