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TREO Abdominal Stent-Graft System
Bolton Medical Inc. · Model 28-L2-09-140U · UDI-DI 08435761052180
MIH
Prescription
0
510(k) clearances
71,804
Adverse events (7,074 deaths)
176
Recalls
34
Facilities
Description
Endovascular Stent-Graft System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-19 | W L Gore & Associates, Inc. | Due to catheter separation |
| 2026-04-22 | Bolton Medical Inc. | Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. |
| 2025-09-18 | Cook Medical Incorporated | Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization. |
| 2024-02-22 | Bolton Medical Inc. | The stent-graft inside the delivery system was the incorrect size. |
| 2023-05-03 | Bolton Medical Inc. | Potential for the incorrect size stent-graft than the printed carton label. |
| 2022-12-20 | Bolton Medical Inc. | The product may be shorter than packaging indicates |
| 2022-12-20 | Bolton Medical Inc. | The product may be shorter than packaging indicates |
| 2021-12-21 | Medtronic Vascular, Inc. | Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during |
| 2021-10-15 | Medtronic Vascular, Inc. | Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube. |
| 2021-10-15 | Medtronic Vascular, Inc. | During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.