Device recall
Z-1300-2008: Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm,.070 in…
FDA device recall · Class III · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-1300-2008 |
|---|---|
| Recall event | 46785 |
| Product | Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft lenght, 90 cm, Catalon Number: 34356-446, UPN H749343564460, 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