Device recall
Z-0728-2020: S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System…
FDA device recall · Class II · Cardinal Health Inc.
Key facts
| Recall number (Z-number) | Z-0728-2020 |
|---|---|
| Recall event | 84228 |
| Product | S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system. The stent is laser cut from a solid nitinol… |
| Product code | NIO |
| Recalling firm | Cardinal Health Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P020036 |
| FEI number | 3004008697 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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