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Medtronic Inc. Cardiac Rhythm Disease Management recalls Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224,
Recalled July 3, 2013 · FDA recall Z-1564-2013 · 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. · FDA Class II
Units
15
Sold at
Internationally distributed: to countries of Germany and Poland.
Description
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.
Product
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.
Manufacturer(s)
Medtronic Inc. Cardiac Rhythm Disease Management
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →