Device recall
Z-1136-2020: NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X…
FDA device recall · Class I · Abbott Vascular
Key facts
| Recall number (Z-number) | Z-1136-2020 |
|---|---|
| Recall event | 84826 |
| Product | NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b)… |
| Product code | LOX |
| Recalling firm | Abbott Vascular |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 16, 2024 |
| 510(k) numbers | K103153, K110134 |
| FEI number | 2024168 |
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