Class I — Bolton Medical Inc.
| Recalling firm | BOLTON MEDICAL, INC. |
|---|---|
| Registered facility | BOLTON MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. |
| 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 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U 28-N4-42-114-42U … |
| Distribution | Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom. |
| Initiated | 2026-04-22 |
| Classified | 2026-05-22 |
| Recall number | Z-2160-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Bolton Medical Inc. (Z-2160-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98729/
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