RelayPro Thoracic Stent-Graft System 28-M4-38-190-38URecalls & 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 00843576149939), received between Feb 24, 2025 and Feb 24, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Seal” (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
- Failure to Seal1
Patient problems
- Aneurysm expansion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2025Failure to Seal; Failure to Seal
"CT IMAGING SHOWED STENT GRAFT INDUCED NEW ENTRY TEAR WITH RAPIDLY GROWING DESCENDING DISTAL AORTIC ANEURYSM. PI DETERMINED THE EVENT RELATED TO THE DEVICE (MAIN BODY). CELIAC ARTERY STENOSIS AND FEVAR UP TO ZONE 6 DISTALLY WAS THE ACTION TAKE REGARDING THIS EVENT. EVENT HAS BEEN RESOLVED WITHOUT SEQUALAE. NOTE THAT AN EVENT INVOLVING THESE DEVICES WAS PREVIOUSLY REPORTED AND INVESTIGATED UNDER COMPLAINT NUMBER (B)(4)." PATIENT OUTCOME: "PI MONITORING EVENT; WILL REVIEW IMAGES AT NEXT F/U."
Patient problems: Aneurysm expansion
MAUDE report 21451927 ↗
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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