Device recall
Z-1383-2024: RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft…
FDA device recall · Class II · Bolton Medical Inc.
Key facts
| Recall number (Z-number) | Z-1383-2024 |
|---|---|
| Recall event | 93873 |
| Product | RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part number 28-M4-36-250-32S… |
| Product code | MIH |
| Recalling firm | Bolton Medical Inc. |
| Recall class | Class II |
| Status | Completed |
| 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