Drug recall
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot #…
FDA recall event 65458 · Class II · Medtronic Inc. Cardiac Rhythm Disease Management
Key facts
| Event ID | 65458 |
|---|---|
| Recall numbers | Z-1564-2013 |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 12, 2013 |
| Report date | Jul 3, 2013 |
| Termination date | Nov 19, 2013 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 2182208 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: