Reported Jan 29, 2025 · Ongoing
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx…
Microvention Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MICROVENTION INC. · 35 Enterprise · Aliso Viejo, CA · 92656
Is this the product you have?
- Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating
- REFMC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
- Lot codes and dates
- Lot # 0000629846/UDI: (01)00816777027634
- Amount recalled
- 107 units
Why it was recalled
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
This product could cause temporary or reversible health problems — stop using it.
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