RelayPro Thoracic Stent-Graft System 28-N4-38-250-28URecalls & 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 00843576171428), received between Apr 9, 2026 and Apr 9, 2026 — 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
Most reported problems
Device problems
- Device Endoleak1
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 9, 2026Device Endoleak
"PRIOR TO TEVAR, THEY PLUGGED THE LSA AND DID A BYPASS TO THE CAROTID. PLAN TO LAND RELAYPRO TAPERFIT 38/28 X 250 MM INSIDE PREVIOUS THORAFLEX GRAFT 30/36. AFTER WE DELIVERED THE RELAYPRO INSIDE THE THORAFLEX, WE DID A RUN AND STILL HAD A LEAK. WE PLACED A SECOND STENT GRAFT MORE PROXIMALLY (CTAG --4040 MM) AND THERE WAS STILL A LEAK. FINALLY, PLACED A THIRD GRAFT MORE DISTAL (CTAG) 37/31 AND THE LEAK WAS GONE. WE ARE UNSURE WHAT THE ACTUAL CAUSE WAS BUT DR. (B)(6) THOUGHT THERE MIGHT BE A TEAR IN THE GRAFT." PATIENT OUTCOME: "NO PATIENT RELATED ISSUES."
Patient problems: Clinical Endoleak
MAUDE report 24829376 ↗
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, ClassifiedRelayPro 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 · CompletedRELAY 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
Other System, Endovascular Graft, Aortic Aneurysm Treatment devices
- Endurant® IIs ESBF2814C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls34 deaths254 reports
- Endurant® IIs ESBF3214C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls19 deaths173 reports
- Endurant® IIs ESBF3614C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall37 deaths214 reports
- Endurant® IIs ESBF2514C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls18 deaths136 reports
- Endurant® IIs ESBF2314C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls9 deaths60 reports
- RelayPro Thoracic Stent-Graft System 28-N4-34-154-34UBolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment3 recalls7 reports
- Vela Proximal Endograft System A34-34/C100-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths152 reports
- Endurant® II ETCF2828C49EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls7 deaths44 reports
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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