TREO Abdominal Stent-Graft System 28-L2-09-160URecalls & reported problems
Bolton Medical Inc. · Endovascular Stent-Graft System · Class 3 · Implant
All models of TREO Abdominal Stent-Graft System (73)
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 00843576152250), received between Mar 12, 2026 and Mar 12, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 other recall cover devices cleared under the same FDA submission (P190015); 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
- Insufficient Device Problem Information1
Patient problems
- Coronary obstruction/occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 12, 2026Insufficient Device Problem Information
"LIMB OCCLUSION ON RIGHT SIDE OF PATIENT." PATIENT OUTCOME: "ADDITIONAL PROCEDURE REQUIRED"
Patient problems: Coronary obstruction/occlusion
MAUDE report 24579673 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P190015. One submission often covers many models, so check the product and lot details in each record.
- Z-1689-2023 · May 3, 2023 · Open, ClassifiedThe TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graf
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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