The Recall Desk

Manufacturer

Trivascular, Inc

3 recalls in our database name Trivascular, Inc as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2014-11-12

Of the 3 recalls from Trivascular, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-0125-2015·2014-11-12

    TriVascular Recalls Ovation Prime Abdominal Stent Grafts Due to Injection Issue

    TriVascular is recalling specific lots of Ovation Prime Abdominal Stent Grafts because the fill polymer syringe may empty rapidly during the implant procedure.

    Product
    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).
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1297-2014·2014-04-02

    TriVascular Ovation Prime Abdominal Stent Graft System Instructions for Use Update

    TriVascular, Inc. is notifying European physician users of the Ovation Prime Abdominal Stent Graft System about changes to the Instructions for Use.

    Product
    Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurys
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0288-2013·2012-11-21

    Trivascular Recalls Fill Polymer Kits Due to Potential Stopcock Leaks

    Trivascular is recalling 41 units of Fill Polymer Kits in European distributor inventory due to potential stopcock cracks that may cause leaks.

    Product
    TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneu
    Category
    Medical Device
    Distribution
    Distributed nationwide