Device recall
Z-0730-2020: Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T…
FDA device recall · Class II · Cardinal Health Inc.
Key facts
| Recall number (Z-number) | Z-0730-2020 |
|---|---|
| Recall event | 84228 |
| Product | Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents contain tantalum markers at… |
| Product code | NIP |
| Recalling firm | Cardinal Health Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 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