Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-1828-2021 · Posted None

Recalling FirmMICROVENTION INC.
Recall StatusTerminated
Product CodeDQY
Date Initiated2021-04-21
Date Terminated2024-02-16

Reason for Recall

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

Firm Action

On 04/30/ 2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via mail/hand delivery/phone to customers informing them that a limited-quantity of microcatheters with international labeling, which has some differences with US-cleared labeling, was inadvertently shipped to U.S. customers

Root Cause

Labeling Change Control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)MicroVention, Inc. · 2019-12-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑