Recall Z-1564-2013 ยท DQY Catheter, Percutaneous
Medtronic Inc. Cardiac Rhythm Disease Management
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.
| Date | Jun 21, 2013 (initiated Jun 12, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| 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. |
| Quantity | 15 |
| Distribution | Internationally distributed: to countries of Germany and Poland. |
| FDA record | Open on fda.gov |