FDA Enforcement
Class II
Ongoing
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Recall: Z-0990-2025
·
Reported January 29, 2025
Enforcement
- Recall Number
- Z-0990-2025
- Event ID
- 95962
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MICROVENTION INC.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 29, 2025
- Initiation Date
- December 2, 2024
- Classification Date
- January 17, 2025
- Address
- 35 Enterprise, Aliso Viejo, CA, 92656, United States
Description
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Reason
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Code Info
Lot # 0000629846/UDI: (01)00816777027634
Distribution
US: None OUS: China
Quantity
107 units