FDA Device recall Z-1564-2013
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The…
- FDA Device
- Class II
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class II recall of Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The… by Medtronic Cardiac Rhythm Disease Management, citing 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 cat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1564-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-12 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Cardiac Rhythm Disease Management |
| Distribution | n/a |
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.
Reason
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.
Identifiers
| code_info | Model # LA8EBU45SH, Lot # 0006722866 and Model # LA6IMAD, Lot # 0006724224. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1564-2013%22
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