Device recall
Z-2160-2026: RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers…
FDA device recall · Class I · Bolton Medical Inc.
Key facts
| Recall number (Z-number) | Z-2160-2026 |
|---|---|
| Recall event | 98729 |
| Product | RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U… |
| Product code | MIH |
| Recalling firm | Bolton Medical Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P200045 |
| FEI number | 1000135961 |
At a glance
- None Linked 510(k)s
- 1–9 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