Device recall
Z-1091-04: ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012…
FDA device recall · Class II · Fox Hollow Technologies
Key facts
| Recall number (Z-number) | Z-1091-04 |
|---|---|
| Recall event | 29443 |
| Product | ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufactured by: FoxHollow Technologies, Redwood City, CA 94063 |
| Product code | --- |
| Recalling firm | Fox Hollow Technologies |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2004 |
| 510(k) numbers | K024243 |
| FEI number | 3004904811 |
At a glance
- 1–9 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