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FDA-Device2026-06-03Class IPROCESSING DEFECT

Bolton Medical RelayPro Thoracic Stent-Graft System recalled for proximal clasp disconnection risk

Bolton Medical
OTHERNationwide distribution

Bolton Medical RelayPro stent-graft recalled for deployment risk

The proximal clasp on Bolton Medical's RelayPro Thoracic Stent-Graft System may disconnect from the outer control tube during use. This disconnection could prevent the stent graft from being released properly from its delivery system. The FDA has issued a labeling update to inform physicians and hospitals of this potential issue.

  • If you are a healthcare provider or hospital with these devices, review the updated labeling immediately.
  • Contact Bolton Medical for guidance on affected lot numbers and recommended actions.
  • Do not use affected devices until you have confirmed the appropriate precautions or replacement status with Bolton Medical.
Hazard

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

Sold states
Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.
Manufactured in
799 International Pkwy, Sunrise, FL, United States
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 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 28-N4-42-159-38U 28-N4-42-159-42U 28-N4-42-204-38U 28-N4-42-204-42U 28-N4-42-259-42U 28-N4-44-114-44U 28-N4-44-164-40U 28-N4-44-164-44U 28-N4-44-209-40U 28-N4-44-209-44U 28-N4-44-259-40U 28-N4-44-259-44U 28-N4-46-114-46U 28-N4-46-164-42U 28-N4-46-164-46U 28-N4-46-209-42U 28-N4-46-209-46U 28-N4-46-259-42U

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2160-2026

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