Device recall
Z-0477-2015: 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device…
FDA device recall · Class II · ZOLL Circulation, Inc.
Key facts
| Recall number (Z-number) | Z-0477-2015 |
|---|---|
| Recall event | 69735 |
| Product | 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device… |
| Product code | PAV |
| Recalling firm | ZOLL Circulation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 26, 2014 |
| FEI number | 3003793491 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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