Device recall
Z-1315-04: ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single…
FDA device recall · Class II · Datascope Interventional Products Division
Key facts
| Recall number (Z-number) | Z-1315-04 |
|---|---|
| Recall event | 29517 |
| Product | ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton. |
| Product code | MCW |
| Recalling firm | Datascope Interventional Products Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 22, 2004 |
| 510(k) numbers | K031610 |
| FEI number | 3003071194 |
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