Device recall
Z-1564-2013: Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F…
FDA device recall · Class II · Medtronic Inc. Cardiac Rhythm Disease Management
Key facts
| Recall number (Z-number) | Z-1564-2013 |
|---|---|
| Recall event | 65458 |
| 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… |
| Product code | DQY |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 19, 2013 |
| 510(k) numbers | K021256, K103386 |
| FEI number | 2182208 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database