The Recall Desk
CriticalFDA (Devices)·Z-0116-2017·Announced 2016-11-02

St Jude Medical Recalls Implantable Defibrillators Due to Battery Defect

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

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

St Jude Medical is recalling specific models of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The affected devices include the Unify, Unify Quadra, Unify Assura, Fortify, and Fortify Assura models.

The recall is due to a defect where a lithium cluster within the battery can cause a short circuit, leading to premature battery depletion. This issue affects 204,785 units that 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 instructions on monitoring the device and potential replacement. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The recalled product

Product
Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pac
Manufacturer
St Jude Medical Inc.
Category
Medical Device — Implantable Cardioverter 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 →

Related recalls

Same manufacturer · St Jude Medical Inc.

See all →

Same hazard · battery failure

See all →