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.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving labeling discrepancy with no reported illnesses, injuries, or deaths. The hazard is documentation-related rather than product-performance related, warranting the lowest severity tier.
Plain-English summary
MicroVention Inc. is recalling certain VIA Microcatheter VIA 17 (Catalog Number VIA-17-154-01) units because they were inadvertently shipped with international labeling instead of US-cleared labeling. The international labels contain differences from the approved US labeling.
The affected microcatheters were distributed nationwide in Florida, Iowa, Michigan, Minnesota, Tennessee, and Texas. The specific lot numbers involved are 19071320 and 20011412PM.
Customers who have received these units should contact MicroVention Inc. for replacement units with correct US labeling or further instructions. Physicians and facilities should verify their product documentation and obtain replacements with proper US-approved labeling.
The recalled product
- 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.
- Manufacturer
- MICROVENTION INC.
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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