Device recall
Z-0070-2012: LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port The Pruitt F3 Carotid…
FDA device recall · Class II · Lemaitre Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-0070-2012 |
|---|---|
| Recall event | 60007 |
| Product | LeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to… |
| Product code | MJN |
| Recalling firm | Lemaitre Vascular, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 14, 2012 |
| 510(k) numbers | K051067 |
| FEI number | 1220948 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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