The Recall Desk

FDA (Devices) recall action 88024

MICROVENTION INC. recalled 3 products on 2021-06-16

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2021-06-16
Critical
0
Units
—

Why these products were recalled

Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2021-06-16

    VIA Microcatheter VIA 21 Recalled for International Labeling Error

    MICROVENTION INC. is recalling VIA Microcatheter VIA 21 units (Lot 19110403M) because they were shipped with international labeling instead of FDA-cleared US labeling.

    Product
    VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2021-06-16

    VIA Microcatheter shipped with incorrect international labeling instead of US labels

    MICROVENTION INC. is recalling VIA Microcatheter units that were inadvertently shipped with international labeling instead of US-cleared labeling. Units were distributed in six U.S. states.

    Product
    VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
    Category
    Distribution
    6 states
  • LowFDA (Devices)··2021-06-16

    VIA Microcatheter recalled due to incorrect international labeling shipped to US

    MicroVention is recalling certain VIA Microcatheter units that were shipped with international labeling instead of US-approved labeling. Affected units were distributed across six US states.

    Product
    VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
    Category
    Distribution
    6 states