Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1689-2023 — The 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-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery system that is advanc

U.S. FDA — Device Enforcement · United States · 2023-05-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1689-2023
Date of alert: 2023-05-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bolton Medical Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00843576151963

Reported risk: Potential for the incorrect size stent-graft than the printed carton label.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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