RelayPro Thoracic Stent-Graft System recall: Labeling Error
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…
Why was RelayPro Thoracic Stent-Graft System recalled?
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots/(Ref Number/Proximal Diameter/DI)28-N4-32-104-32U/ 32/ (01)00843576150461; 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; 28-N4-38-199-34U/ 38/ (01)00843576151086; 28-N4-38-199-38U/ 38/ (01)00843576150751; 28-N4-38-259-38U/ 38/ (01)00843576150881; 28-N4-40-114-40U/ 40/ (01)00843576150508; 28-N4-40-154-36U/ 40/ (01)00843576150997; 28-N4-40-154-40U/ 40/ (01)00843576150638; 28-N4-40-204-36U/ 40/ (01)00843576151093; 28-N4-40-204-40U/ 40/ (01)00843576150768; 28-N4-40-259-40U/ 40/ (01)00843576150898; 28-N4-42-114-42U/ 42/ (01)00843576150515; 28-N4-42-159-38U/ 42/ (01)00843576151000; 28-N4-42-159-42U/ 42/ (01)00843576150645; 28-N4-42-204-38U/ 42/ (01)00843576151109; 28-N4-42-204-42U/ 42/ (01)00843576150775; 28-N4-42-259-42U/ 42/ (01)00843576150904; 28-N4-44-114-44U/ 44/ (01)00843576150522; 28-N4-44-164-40U/ 44/ (01)00843576151017; 28-N4-44-164-44U/ 44/ (01)00843576150652; 28-N4-44-209-40U/ 44/ (01)00843576151116; 28-N4-44-209-44U/ 44/ (01)00843576150782; 28-N4-44-259-40U/ 44/ (01)00843576151215; 28-N4-44-259-44U/ 44/ (01)00843576150911; 28-N4-46-114-46U/ 46/ (01)00843576150539; 28-N4-46-164-42U/ 46/ (01)00843576151024; 28-N4-46-164-46U/ 46/ (01)00843576150669; 28-N4-46-209-42U/ 46/ (01)00843576151123; 28-N4-46-209-46U/ 46/ (01)00843576150799; 28-N4-46-259-42U/ 46/ (01)00843576151222
- 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…
- Recalling firm
- Bolton Medical Inc.
- Distribution
- Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.
- Recall date
- June 3, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)