Device product
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Z-0990-2025
Product summary
- Event
- Event 95962
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 107 units
- Official record key
device-enforcement:Z-0990-2025
Official wording
Reason: Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Code information: Lot # 0000629846/UDI: (01)00816777027634
Distribution pattern: US: None OUS: China
Derived failure modes
-
Labeling or packaging
incomplete seal
-
Sterility assurance
Sterility assurance; microcatheter inner packaging may contain incomplete