The Recall Desk
HighFDA (Devices)·Z-2160-2026·Announced 2026-06-03

[pending] RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-1

Pending LLM rewrite. Source: FDA_DEVICE Z-2160-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.

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 28-
Manufacturer
Bolton Medical Inc.
Category
Medical Device — Devices

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

Distribution scope not specified by the agency.

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