Device recall
Z-0309-2017: Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro…
FDA device recall · Class I · Micro Therapeutics Inc, Dba Ev3 Neurovascular
Key facts
| Recall number (Z-number) | Z-0309-2017 |
|---|---|
| Recall event | 75358 |
| Product | Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials… |
| Product code | KRA |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 11, 2017 |
| PMA numbers | P100018 |
| FEI number | 3004904811 |
At a glance
- None 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