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

RelayPro Thoracic Stent-Graft System Proximal Clasp Disconnection

Bolton Medical's RelayPro Thoracic Stent-Graft System may fail to release from its delivery system due to proximal clasp disconnection. This FDA Class I recall affects multiple device configurations distributed worldwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I device recall, the highest regulatory category, indicating a serious hazard involving potential device failure that could compromise a critical surgical procedure. No adverse events have been reported to date.

Plain-English summary

Bolton Medical Inc. is recalling the RelayPro Thoracic Stent-Graft System in multiple sizes and configurations. This device is used in thoracic aortic surgery to treat or repair the thoracic aorta.

The proximal clasp connecting the outer control tube may become disconnected. If this occurs, the stent graft may not release properly from the delivery system during implantation, potentially affecting the surgical outcome.

This is an FDA Class I recall affecting all lots of the device. The recalled devices have been distributed worldwide, including to the United States, Puerto Rico, Argentina, Chile, Canada, Colombia, Mexico, and the United Kingdom. Healthcare providers should take appropriate action in response to this recall.

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 — Thoracic Stent-Graft
Hazard
  • device-deployment-failure
  • proximal-clasp-disconnection

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.

Related recalls

Same category