Drug recall
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro…
FDA recall event 63188 · Class II · Micro Therapeutics Inc, Dba Ev3 Neurovascular
Key facts
| Event ID | 63188 |
|---|---|
| Recall numbers | Z-2471-2012, Z-2472-2012 |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Product type | Devices |
| Products | Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective…, UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled. |
| Initiation date | Sep 23, 2011 |
| Report date | Oct 3, 2012 |
| Termination date | Sep 28, 2012 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 1000220862 |
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: