RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-3...
Reason for Recall / Hazard
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Sunrise |
| State | FL |
| Event id | 98729 |
| Address 1 | 799 International Pkwy |
| 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)00843576... [TRUNCATED] |
| Postal code | 33325-6220 |
| Report date | 20260603 |
| Product type | Devices |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260422 |
| Center classification date | 20260522 |
Overview
- Recalling FirmBolton Medical Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.