RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-
Summary
The FDA issued a Class I for RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-3 by Bolton Medical Inc.. Reason: Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the deliver.
Details
Source
Device Recall
External ID
Z-2160-2026
Action Date
2026-06-03
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Reason for Recall
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Distribution
Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-22
Company
Sunrise, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 129 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bolton Medical Inc. has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bolton Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bolton Medical Inc. have FDA actions?
Bolton Medical Inc. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2160-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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