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RelayPro Thoracic Stent-Graft System 28-N4-32-110-38U

by Bolton Medical Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00843576168930 UDI-DI Date4 May 2022ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2160-2026 FDA Class I initiated 22 Apr 2026

    Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.

    • Completed Z-1383-2024 FDA Class II initiated 22 Feb 2024

    The stent-graft inside the delivery system was the incorrect size.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
RelayPro Thoracic Stent-Graft System
Generic Name
Descending thoracic aorta/aortic isthmus endovascular stent-graft
Model / Ref / Catalog
28-N4-32-110-38U
Primary DI / UDI-DI
00843576168930
PMA Number
FDA Product Code
MIH
GMDN Term
Descending thoracic aorta/aortic isthmus endovascular stent-graft
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Outer Diameter — 32 Millimeter
Outer Diameter — 38 Millimeter
Length — 107 Millimeter
Catheter Gauge — 22 French

Related devices

Category: Descending thoracic aorta endovascular stent-graft

Cleared under the same submission (P200045)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No