FDAFDA · Food and drugs·Recall number Z-0990-2025
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Published January 29, 2025 · Recall initiated: December 2, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MICROVENTION INC.
- Distributor
- US: None OUS: China
- Lot
- Lot # 0000629846/UDI: (01)00816777027634
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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