Drug recall
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U…
FDA recall event 98729 · Class I · Bolton Medical Inc.
Key facts
| Event ID | 98729 |
|---|---|
| Recall numbers | Z-2160-2026 |
| Recalling firm | Bolton Medical Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. |
| Initiation date | Apr 22, 2026 |
| Report date | Jun 3, 2026 |
| City | Sunrise |
| State | FL |
| Country | United States |
| FEI number | 1000135961 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: