RelayPro Thoracic Stent-Graft System 28-M4-38-145-38URecalls & reported problems

Bolton Medical Inc. · Endovascular Stent-Graft System · Class 3 · Implant

All models of RelayPro Thoracic Stent-Graft System (127)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576149809), received between Apr 25, 2025 and Apr 25, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Endoleak” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P200045); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Endoleak1
Failure to Seal1

Patient problems

Clinical Endoleak1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryApr 25, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak
"SUBJECT PRESENTED A FUSIFORM AORTIC ANEURYSM AND WAS IMPLANTED WITH 1 RELAYPRO BS DEVICE ON (B)(6) 2025. SUBJECT SPEND ONE DAY IN THE HOSPITAL AND WAS DISCHARGED BACK TO PRE-OP LIVING LOCATION ON (B)(6) 2025. AT THE END OF THE PROCEDURE, SUBJECT WAS FOUND TO HAVE A SMALL TYPE 1A ENDOLEAK INTRAOPERATIVELY AFTER DEPLOYMENT. EVENT WAS SITE REPORTED AS RELATED TO PROCEDURE AND MAIN BODY OF DEVICE. EVENT WAS RESOLVED WITHOUT SEQUALAE ON (B)(6) 2025. CT IMAGING FROM THE EARLY F/U VISIT ON (B)(6) 2025, SHOWED TYPE 3 ENDOLEAK FROM OVERLAPPING REGION OF TEVAR. THIS EVENT HAS BEEN SITE REPORTED AS RELATED TO PROCEDURE AND MAIN BODY OF DEVICE AND IS ONGOING." PATIENT OUTCOME: "PI MONITORING EVENT; AND DETERMINE IF INTERVENTION IS NEEDED."
Patient problems: Clinical Endoleak
MAUDE report 21912300 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P200045. One submission often covers many models, so check the product and lot details in each record.

Z-2160-2026 · Apr 22, 2026 · Open, Classified
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-
Z-1383-2024 · Feb 22, 2024 · Completed
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 2

Device details

UDI-DI	`00843576149809`
Brand	RelayPro Thoracic Stent-Graft System
Model	28-M4-38-145-38U
Company	Bolton Medical Inc.
Product code	MIH · System, Endovascular Graft, Aortic Aneurysm Treatment
Class	Class 3
FDA submission	P200045
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Dec 31, 2024

Device type (GMDN): Descending thoracic aorta endovascular stent-graft

A non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]; it is not intended for implantation within the aortic arch. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.

Other System, Endovascular Graft, Aortic Aneurysm Treatment devices

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Endurant® IIs ESBF3214C103E
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2 recalls19 deaths173 reports
Endurant® IIs ESBF3614C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Endurant® IIs ESBF2514C103E
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2 recalls18 deaths136 reports
Endurant® IIs ESBF2314C103E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls9 deaths60 reports
RelayPro Thoracic Stent-Graft System 28-N4-34-154-34U
Bolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment
3 recalls7 reports
Vela Proximal Endograft System A34-34/C100-O20 V
Endologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment
3 deaths152 reports
Endurant® II ETCF2828C49E
Medtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
2 recalls7 deaths44 reports

All System, Endovascular Graft, Aortic Aneurysm Treatment devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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