Z-1829-2021 Class III Terminated

Recalled by MICROVENTION INC. — Aliso Viejo, CA

Recall Details

Product Type
Devices
Report Date
June 16, 2021
Initiation Date
April 21, 2021
Termination Date
February 16, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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 for Recall

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

Distribution Pattern

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

Code Information

Catalog Number: VIA-21-154-01 UDI: (01)00842429101650(11)191104(17)221031(10)19110403M Lot Number: 19110403M