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.
What this means for you
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 FDA Class III recall involves a labeling discrepancy where international labeling was shipped instead of US-cleared labeling. No illnesses or injuries have been reported. Per the rubric, Class III recalls typically score 1 or 2, and minor labeling errors score 2.
Plain-English summary
MICROVENTION INC. is recalling VIA Microcatheter units due to inadvertent shipment with international labeling that differs from the labeling that is cleared for use in the United States. The affected product is the VIA Microcatheter VIA 27 (Catalog Number VIA-27-154-01), a single-lumen catheter designed for introduction over a steerable guidewire into the vasculature.
The recalled units were distributed nationwide to customers in Florida, Iowa, Michigan, Minnesota, Tennessee, and Texas. The affected lot is Lot Number 19072208.
Healthcare providers and patients who have received these devices should consult with MICROVENTION INC. or their healthcare provider regarding the labeling differences and proper device use. Customers in possession of the recalled units should contact the manufacturer for instructions on returning or replacing the product.
The recalled product
- 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.
- Manufacturer
- MICROVENTION INC.
- Hazard
- mis-labeling
Distribution
Distributed nationwide across the United States.
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