Device recall
Z-0328-2017: FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for…
FDA device recall · Class I · SentreHeart Inc
Key facts
| Recall number (Z-number) | Z-0328-2017 |
|---|---|
| Recall event | 75395 |
| Product | FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures. |
| Product code | DQX |
| Recalling firm | SentreHeart Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 1, 2017 |
| 510(k) numbers | K080364 |
| FEI number | 3006482885 |
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