Device recall
Z-0729-2020: Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System…
FDA device recall · Class II · Cardinal Health Inc.
Key facts
| Recall number (Z-number) | Z-0729-2020 |
|---|---|
| Recall event | 84228 |
| Product | Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid nitinol tube into a fine… |
| Product code | NIM |
| Recalling firm | Cardinal Health Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P030047 |
| FEI number | 3004008697 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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