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Bolton Medical Thoracic Stent-Graft Delivery System
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MEDICAL DEVICE RECALLCRITICAL

Bolton Medical Thoracic Stent-Graft Delivery System

Bolton Medical Inc. is recalling its Thoracic Stent-Graft delivery system due to a labeling update concerning disconnection of the proximal clasp from the outer control tube, which may prevent release of the stent-graft from the delivery system.

What to do

Consumers should contact Bolton Medical Inc. or their healthcare provider for information regarding the labeling update, and follow the updated instructions for use to ensure proper deployment of the device.

Recalled
Listed
Updated
Recall No.
Z-2160-2026
Agency
FDA
Firm
Bolton Medical Inc.
Recall ID
98729
Status
ONGOING

Why it was recalled

Bolton Medical Inc. is recalling its Thoracic Stent-Graft delivery system due to a labeling update concerning disconnection of the proximal clasp from the outer control tube, which may prevent release of the stent-graft from the delivery system. The recall covers various catalog numbers and the full list is available on the agency detail page.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

ProductLot codeUDI-DI
28–00843576150461, 00843576150959, 00843576150591, 00843576151055, 00843576150720, 00843576150850, 00843576150478, 00843576150966, 00843576150607, 00843576151062, 00843576150737, 00843576150867, 00843576150485, 00843576150973, 00843576150614, 00843576151079, 00843576150744, 00843576150874, 00843576150492, 00843576150980
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-N4-46-259-42UAll Lots/(Ref Number/Proximal Diameter/DI)28-N4-32-104-32U/ 32/ (01)00843576150461–

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-07 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification