Product Wiki · Recalls · Health Canada — Medical Devices

UNIFY, FORTIFY AND QUADRA (2016-10-07) — recall 55796

Health Canada — Medical Devices · Canada · 2016-10-07 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55796
Date of alert
2016-10-07
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: St. Jude Medical has identified a risk of premature battery depletion associated with certain St. Jude medical implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices manufactured before May 23, 2015. There is evidence of lithium material in the form of "clusters" in the battery. Some devices exhibited visible clusters bridging the cathode and anode causing shorting. Lithium cluster formation is a known phenomenon with this type of battery.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/unify-fortify-and-quadra-2016-

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