FDA recall Z-1830-2021

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.

Reason for recall

Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

Distribution

U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.

Key facts

Status

Terminated

Initiation date

2021-04-21

Report date

2021-06-16

Termination date

2024-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aliso Viejo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1830-2021