FDA recall, , High risk
RelayPro Thoracic Stent-Graft System
The RelayPro Thoracic Stent-Graft System may have a proximal clasp disconnection that prevents release from the delivery system.
Summary by Recall Canary from the FDA notice
What happened
Bolton Medical Inc., of Sunrise, Florida, recalled the RelayPro Thoracic Stent-Graft System in various sizes after an FDA labeling update concerning a proximal clasp disconnection from the outer control tube, which may prevent the stent graft from being released from the delivery system.
The recall began on April 22, 2026, and was added to the FDA's Enforcement Report on May 22, 2026, with distribution in Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
RelayPro Thoracic Stent-Graft System (various sizes)
- UDI-DI
- 00843576150461
- 00843576150959
- 00843576150591
- 00843576151055
- 00843576150720
- 00843576150850
- 00843576150478
- 00843576150966
- 00843576150607
- 00843576151062
- 00843576150737
- 00843576150867
- 00843576150485
- 00843576150973
- 00843576150614
- 00843576151079
- 00843576150744
- 00843576150874
- 00843576150492
- 00843576150980
- 00843576150621
- 00843576151086
- 00843576150751
- 00843576150881
- 00843576150508
- 00843576150997
- 00843576150638
- 00843576151093
- 00843576150768
- 00843576150898
- 00843576150515
- 00843576151000
- 00843576150645
- 00843576151109
- 00843576150775
- 00843576150904
- 00843576150522
- 00843576151017
- 00843576150652
- 00843576151116
- 00843576150782
- 00843576151215
- 00843576150911
- 00843576150539
- 00843576151024
- 00843576150669
- 00843576151123
- 00843576150799
- 00843576151222
- Reference code
- 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
- Lot code
- All Lots/(Ref Number/Proximal Diameter/DI)28-N4-32-104-32U/ 32/ (01)00843576150461
Recall details
- Company began the recall
- Sold in
Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.
- Company
- Bolton Medical Inc.Sunrise, Florida
- Hazard
- Labeling error
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98729
- Recall number
- Z-2160-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
