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.
FDA Recall Z-1564-2013 · Posted 2013-06-21
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Recalling FirmMedtronic Inc. Cardiac Rhythm Disease Management
Recall StatusTerminated
Product CodeDQY
Date Initiated2013-06-12
Date Terminated2013-11-19
Product Quantity15
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.
Firm Action
Medtronic "Urgent Field Safety Notice" letter dated June 2013 to all affected customers. The letter described the affected product, problem and actions to be taken. The letter instructed customers to remove and quarantine all affected product within their inventory and return the affected product to Medtronic. For questions contact your local Medtronic representative.
Root Cause
Labeling mix-ups
Distribution Pattern
Internationally distributed: to countries of Germany and Poland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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