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

Recall Z-0125-2015 — Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).

U.S. FDA — Device Enforcement · United States · 2014-09-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0125-2015
Date of alert
2014-09-20
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Trivascular, Inc
Product category
device
Product type
Devices
Reported risk: TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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