Home / Recalls / Medtronic Inc. Cardiac Rhythm Disease Management / Z-1564-2013

Z-1564-2013 Class II Terminated

Recalled by Medtronic Inc. Cardiac Rhythm Disease Management — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
July 3, 2013
Initiation Date
June 12, 2013
Termination Date
November 19, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Internationally distributed: to countries of Germany and Poland.

Code Information

Model # LA8EBU45SH, Lot # 0006722866 and Model # LA6IMAD, Lot # 0006724224.

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