Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40

FDA device recall Z-0116-2017 · posted 2016-10-21 · Terminated

Recall details

Recalling firm

St Jude Medical Inc.

Reason for recall

St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.

Action taken

St. Jude Medical, Inc., sent a customer letter to all affected customers to inform them that St. Jude Medical recently announced a global medical device advisory for a subset of their company's Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The letter informs customers that the cause for Premature Battery Depletion is attributed to the formation of lithium clusters within the battery causing a short circuit. There is a possibility that affected devices may lose battery power within days. Thus far, there have been two (2) deaths and ten (10) serious events (fainting) that may have been associated with premature battery depletion. Customers with questions were instructed to contact www.sjm.com/batteryadvisory, (866) 915-5065.

Root cause

Device Design

Status

Terminated

Product code

LWS

Quantity affected

204,785 units

Distribution

Worldwide Distribution - US (nationwide) and OUS

Date initiated

2016-10-10

Date posted

2016-10-21

Date terminated

2018-09-27

Location

Sylmar, CA