Device recall
Z-1121-04: Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon…
FDA device recall · Class I · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1121-04 |
|---|---|
| Recall event | 29581 |
| Product | Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express 316L stainless steel Stent premounted on a MONORAIL catheter with a Dynaleap balloon. |
| Product code | MAF |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 29, 2005 |
| PMA numbers | P020009 |
| FEI number | 3001451463 |
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