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-
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
- Agency
- FDA Device
- Recall date
- Apr 22, 2026
- Status
- Ongoing
- Company
- Bolton Medical Inc.
1. What product was recalled?
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-
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
Code or lot text: 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
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- 28-N4-32-164-28U/ 32/ (01)00843576150959
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- 28-N4-32-164-32U/ 32/ (01)00843576150591
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- 28-N4-32-209-28U/ 32/ (01)00843576151055
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- 28-N4-32-209-32U/ 32/ (01)00843576150720
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- 28-N4-32-259-32U/ 32/ (01)00843576150850
- LOT
- 28-N4-34-109-34U/ 34/ (01)00843576150478
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- 28-N4-34-154-30U/ 34/ (01)00843576150966
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- 28-N4-34-154-34U/ 34/ (01)00843576150607
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- 28-N4-34-209-30U/ 34/ (01)00843576151062
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- 28-N4-34-209-34U/ 34/ (01)00843576150737
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- 28-N4-34-259-34U/ 34/ (01)00843576150867
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- 28-N4-36-109-36U/ 36/ (01)00843576150485
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- 28-N4-36-154-32U/ 36/ (01)00843576150973
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- 28-N4-36-154-36U/ 36/ (01)00843576150614
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- 28-N4-36-199-32U/ 36/ (01)00843576151079
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- 28-N4-36-199-36U/ 36/ (01)00843576150744
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- 28-N4-36-259-36U/ 36/ (01)00843576150874
- LOT
- 28-N4-38-109-38U/ 38/ (01)00843576150492
- LOT
- 28-N4-38-154-34U/ 38/ (01)00843576150980
- LOT
- 28-N4-38-154-38U/ 38/ (01)00843576150621
- LOT
- 28-N4-38-199-34U/ 38/ (01)00843576151086
- LOT
- 28-N4-38-199-38U/ 38/ (01)00843576150751
- LOT
- 28-N4-38-259-38U/ 38/ (01)00843576150881
- LOT
- 28-N4-40-114-40U/ 40/ (01)00843576150508
- LOT
- 28-N4-40-154-36U/ 40/ (01)00843576150997
- LOT
- 28-N4-40-154-40U/ 40/ (01)00843576150638
- LOT
- 28-N4-40-204-36U/ 40/ (01)00843576151093
- LOT
- 28-N4-40-204-40U/ 40/ (01)00843576150768
- LOT
- 28-N4-40-259-40U/ 40/ (01)00843576150898
- LOT
- 28-N4-42-114-42U/ 42/ (01)00843576150515
- LOT
- 28-N4-42-159-38U/ 42/ (01)00843576151000
- LOT
- 28-N4-42-159-42U/ 42/ (01)00843576150645
- LOT
- 28-N4-42-204-38U/ 42/ (01)00843576151109
- LOT
- 28-N4-42-204-42U/ 42/ (01)00843576150775
- LOT
- 28-N4-42-259-42U/ 42/ (01)00843576150904
- LOT
- 28-N4-44-114-44U/ 44/ (01)00843576150522
- LOT
- 28-N4-44-164-40U/ 44/ (01)00843576151017
- LOT
- 28-N4-44-164-44U/ 44/ (01)00843576150652
- LOT
- 28-N4-44-209-40U/ 44/ (01)00843576151116
- LOT
- 28-N4-44-209-44U/ 44/ (01)00843576150782
- LOT
- 28-N4-44-259-40U/ 44/ (01)00843576151215
- LOT
- 28-N4-44-259-44U/ 44/ (01)00843576150911
- LOT
- 28-N4-46-114-46U/ 46/ (01)00843576150539
- LOT
- 28-N4-46-164-42U/ 46/ (01)00843576151024
- LOT
- 28-N4-46-164-46U/ 46/ (01)00843576150669
- LOT
- 28-N4-46-209-42U/ 46/ (01)00843576151123
- LOT
- 28-N4-46-209-46U/ 46/ (01)00843576150799
- LOT
- 28-N4-46-259-42U/ 46/ (01)00843576151222
- LOT
- All Lots/(Ref Number/Proximal Diameter/DI)28-N4-32-104-32U/ 32/ (01)00843576150461
- RECALL-NUMBER
- Z-2160-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Puerto Rico
View source evidence for state distribution
- Puerto Rico: Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.