Device recall
Z-0551-03: Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0551-03 |
|---|---|
| Recall event | 25487 |
| Product | Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon Catalog # 4544 |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 10, 2004 |
| 510(k) numbers | K970052 |
| FEI number | 3001451463 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
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