Device recall
Z-2244-2009: Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-2244-2009 |
|---|---|
| Recall event | 53143 |
| Product | Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized with Ethylene Oxide. Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. M001182830 18-283 11961001 RENEGADE HI FLO 80/20 M001182840 18-284 11294909 RENEGADE… |
| Product code | KRA |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2012 |
| 510(k) numbers | K000177, K023681 |
| FEI number | 3002095335 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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