Class II
Medical Device Recall: Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
MICROVENTION INC. · December 2, 2024
Reason for Recall
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Distribution
US: None OUS: China
Quantity Affected
107 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0990-2025
Status: ongoing
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