FDA Device recall Z-1829-2021
VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire…
- FDA Device
- Class III
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class III recall of VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire… by Microvention, citing due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1829-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-04-21 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microvention |
| Distribution | US |
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.
Reason
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Identifiers
| code_info | Catalog Number: VIA-21-154-01 UDI: (01)00842429101650(11)191104(17)221031(10)19110403M Lot Number: 19110403M |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1829-2021%22
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