Class III — MICROVENTION INC.
| Recalling firm | MicroVention Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling. |
| 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. |
| Quantity | N/A |
| Distribution | U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX. |
| Initiated | 2021-04-21 |
| Classified | 2021-06-07 |
| Terminated | 2024-02-16 |
| Recall number | Z-1828-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — MICROVENTION INC. (Z-1828-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88024/
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