FDA-Device2013-03-20Class II
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
Sorin Group USA, Inc.
Hazard
Isoline defibrillation leads distributed may have internal insulation breach.
Sold states
Worldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Morocco, The Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Ukraine, Uruguay and the United Kingdom.
Affected count
1376 Isoline leads
Manufactured in
14401 W 65th Way, N/A, Arvada, CO, United States
Products
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0928-2013Don't want to check this manually?
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