FDA-Device2013-07-03Class II
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Medtronic Inc. Cardiac Rhythm Disease Management
Hazard
Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package.
Sold states
Internationally distributed: to countries of Germany and Poland.
Affected count
15
Manufactured in
8200 Coral Sea St NE, Saint Paul, MN, United States
Products
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1564-2013Don't want to check this manually?
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