Device recall
Z-2151-2017: Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS…
FDA device recall · Class I · Abbott Vascular
Key facts
| Recall number (Z-number) | Z-2151-2017 |
|---|---|
| Recall event | 77131 |
| Product | Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo… |
| Product code | PNY |
| Recalling firm | Abbott Vascular |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 16, 2017 |
| PMA numbers | P150023 |
| FEI number | 2024168 |
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