Agency classClass IOur severity:Severe FDA (Devices)·Z-2160-2026·Announced 2026-06-03

RelayPro thoracic stent-graft clasp may not release from delivery system

The RelayPro Thoracic Stent-Graft System is subject to a labeling update concerning proximal clasp disconnection from the outer control tube, which may prevent release of the graft.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.

Plain-English summary

The RelayPro Thoracic Stent-Graft System is being recalled across a range of reference numbers and sizes listed in the recall notice. The quantity is not stated.

The action is a labeling update concerning proximal clasp disconnection from the outer control tube, which may prevent the stent graft from being released from the delivery system. The FDA classified the action as Class I, its most serious classification.

Distribution was worldwide, including the US Territory of Puerto Rico and a number of other countries. The systems are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the reference numbers and device identifiers in the recall notice and follow the updated labeling and instructions issued by the manufacturer.

The recalled product

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…
Manufacturer: Bolton Medical Inc.
Category: Medical Device — Thoracic stent graft
Hazard: deployment-failure
clasp-disconnection
class-i
endovascular

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

28-N4-32-164-28U/ 32/ (01)00843576150959
28-N4-32-164-32U/ 32/ (01)00843576150591
28-N4-32-209-28U/ 32/ (01)00843576151055
28-N4-32-209-32U/ 32/ (01)00843576150720
28-N4-32-259-32U/ 32/ (01)00843576150850
28-N4-34-109-34U/ 34/ (01)00843576150478
28-N4-34-154-30U/ 34/ (01)00843576150966
28-N4-34-154-34U/ 34/ (01)00843576150607
28-N4-34-209-30U/ 34/ (01)00843576151062
28-N4-34-209-34U/ 34/ (01)00843576150737
28-N4-34-259-34U/ 34/ (01)00843576150867
28-N4-36-109-36U/ 36/ (01)00843576150485
28-N4-36-154-32U/ 36/ (01)00843576150973
28-N4-36-154-36U/ 36/ (01)00843576150614
28-N4-36-199-32U/ 36/ (01)00843576151079
28-N4-36-199-36U/ 36/ (01)00843576150744
28-N4-36-259-36U/ 36/ (01)00843576150874
28-N4-38-109-38U/ 38/ (01)00843576150492
28-N4-38-154-34U/ 38/ (01)00843576150980
28-N4-38-154-38U/ 38/ (01)00843576150621

Distribution

Distributed in 1 state:

Same manufacturer · Bolton Medical Inc.

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Same hazard · deployment failure