Recall Z-1828-2021— MICROVENTION INC.

Name: FDA recall Z-1828-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-21

Class III · Terminated

Class III FDA medical device recall by MICROVENTION INC., initiated 2021-04-21, terminated 2024-02-16. It names one FDA 510(k) clearance: K192135. 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.. Reason: Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling..

Recalling firm: MICROVENTION INC.
Classification: Class III
Status: Terminated
Initiated: 2021-04-21
Terminated: 2024-02-16
Firm location: Aliso Viejo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K192135 — VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)MicroVention, Inc.·cleared 2019-12-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.