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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall for labeling discrepancy (international vs. US-cleared labeling). Per the rubric, Class III recalls are typically scored 1-2, and this minor labeling error without reported harm corresponds to Moderate (score 2).
Plain-English summary
MICROVENTION INC. is recalling the VIA Microcatheter VIA 21 (Catalog Number VIA-21-154-01, Lot Number 19110403M). The product is a single-lumen catheter designed for vascular use. The recalled units were inadvertently shipped with international labeling instead of the FDA-cleared US labeling.
The international labeling contains differences from the approved US version. The affected units were distributed nationwide to healthcare facilities in Florida, Iowa, Michigan, Minnesota, Tennessee, and Texas.
This is classified as a Class III recall by the FDA.
The recalled product
- 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.
- Manufacturer
- MICROVENTION INC.
- Hazard
Distribution
Part of a larger recall action
This product is one of 3 recalled by MICROVENTION INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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