Device recall
Z-0935-2008: Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are…
FDA device recall · Class II · Boston Scientific
Key facts
| Recall number (Z-number) | Z-0935-2008 |
|---|---|
| Recall event | 45903 |
| Product | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-301. 6F MULTI PIT 124 (Single Pack). Distal Curve FL4, FR4, PIG 145. 100 and 110 cm Length. Made in Mexico: Parque… |
| Product code | DQO |
| Recalling firm | Boston Scientific |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 23, 2008 |
| 510(k) numbers | K000956, K992123 |
| FEI number | 3002095335 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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