FDA recall Z-0990-2025

MICROVENTION INC. · Class II · device

Product

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

Reason for recall

Sterility assurance; microcatheter inner packaging may contain incomplete seal.

Distribution

US: None OUS: China

Key facts

Status
Ongoing
Initiation date
2024-12-02
Report date
2025-01-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aliso Viejo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0990-2025