Reported Jun 3, 2026 · Ongoing
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U…
Bolton Medical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bolton Medical Inc. · 799 International Pkwy · Sunrise, FL · 33325-6220
Is this the product you have?
- RelayPro Thoracic Stent-Graft System (various
- sizes) Reference numbers
28-N4-32-104-32U28-N4-32-164-28U28-N4-32-164-32U28-N4-32-209-28U28-N4-32-209-32U28-N4-32-259-32U28-N4-34-109-34U28-N4-34-154-30U28-N4-34-154-34U28-N4-34-209-30U28-N4-34-209-34U28-N4-34-259-34U28-N4-36-109-36U28-N4-36-154-32U28-N4-36-154-36U28-N4-36-199-32U28-N4-36-199-36U28-N4-36-259-36U28-N4-38-109-38U28-N4-38-154-34U28-N4-38-154-38U28-N4-38-199-34U28-N4-38-199-38U28-N4-38-259-38U28-N4-40-114-40U28-N4-40-154-36U28-N4-40-154-40U28-N4-40-204-36U28-N4-40-204-40U28-N4-40-259-40U28-N4-42-114-42U28-N4-42-159-38U28-N4-42-159-42U28-N4-42-204-38U28-N4-42-204-42U28-N4-42-259-42U28-N4-44-114-44U28-N4-44-164-40U28-N4-44-164-44U28-N4-44-209-40U28-N4-44-209-44U28-N4-44-259-40U28-N4-44-259-44U28-N4-46-114-46U28-N4-46-164-42U28-N4-46-164-46U28-N4-46-209-42U28-N4-46-209-46U28-N4-46-259-42U
- Lot codes and dates
48 of 48 products · 48 lot codes
Recalled lot codes, grouped by product number Product number Barcode Lot codes and dates 28-N4-32-164-28U32(01)00843576150959
28-N4-32-164-32U32(01)00843576150591
28-N4-32-209-28U32(01)00843576151055
28-N4-32-209-32U32(01)00843576150720
28-N4-32-259-32U32(01)00843576150850
28-N4-34-109-34U34(01)00843576150478
28-N4-34-154-30U34(01)00843576150966
28-N4-34-154-34U34(01)00843576150607
28-N4-34-209-30U34(01)00843576151062
28-N4-34-209-34U34(01)00843576150737
Where it was sold
Why it was recalled
Stop using this product now
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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