FDA Medical devices recall ·
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic… recall
- Recall number
- Z-0990-2025
- Date
- (initiated December 2, 2024)
- Company / brand
- Microvention Inc.
35 Enterprise, Aliso Viejo, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 107 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Why was it recalled?
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 0000629846/UDI: (01)00816777027634
Distribution
US: None OUS: China
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0990-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.