Device recall
Z-0335-2017: Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology…
FDA device recall · Class II · Stryker Neurovascular
Key facts
| Recall number (Z-number) | Z-0335-2017 |
|---|---|
| Recall event | 75447 |
| Product | Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system. |
| Product code | DQY |
| Recalling firm | Stryker Neurovascular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2017 |
| 510(k) numbers | K010853 |
| FEI number | 3008853977 |
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