Device recall
Z-0068-2010: Boston Scientific Liberte Monorail and Over-the-Wire Coronary Stent Systems to…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0068-2010 |
|---|---|
| Recall event | 53435 |
| Product | Boston Scientific Liberte Monorail and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX". The Liberte Coronary Stent System consists of a balloon expandable stainless steel stent, pre-mounted on either a Liberte Monorail (MR) or Liberte Over-the-Wire (OTW) delivery system. The… |
| Product code | MAF |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 2012 |
| PMA numbers | P9681260 |
| FEI number | 3002095335 |
At a glance
- None 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