Medical device recalls Moderate risk

MICROVENTION INC. recalls Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx O…

Recall date
December 2, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0990-2025
FDA classification
Class II
Brand / firm
MICROVENTION INC.
Sold / distributed
US: None OUS: China

Why it was recalled

Sterility assurance; microcatheter inner packaging may contain incomplete seal.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846

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