Device recall
Z-1305-2008: Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve…
FDA device recall · Class III · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1305-2008 |
|---|---|
| Recall event | 46785 |
| Product | Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientific Corp., Maple Grove, MN 55311 |
| Product code | DQY |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 3, 2008 |
| 510(k) numbers | K010874, K020028 |
| FEI number | 3001451463 |
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