FDAFDA · Food and drugs·Recall number Z-1564-2013
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.
Published July 3, 2013 · Recall initiated: June 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Distributor
- Internationally distributed: to countries of Germany and Poland.
- Lot
- Model # LA8EBU45SH, Lot # 0006722866 and Model # LA6IMAD, Lot # 0006724224.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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