Device recall
Z-0132-2013: Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no…
FDA device recall · Class II · Greatbatch Medical
Key facts
| Recall number (Z-number) | Z-0132-2013 |
|---|---|
| Recall event | 63316 |
| Product | Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The… |
| Product code | DYB |
| Recalling firm | Greatbatch Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2014 |
| 510(k) numbers | K101784 |
| FEI number | 2183787 |
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