Recall archive / FDA device enforcement
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx... — FDA record Z-0990-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 2, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- MICROVENTION INC.
- Quantity
- 107 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0990-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # 0000629846/UDI: (01)00816777027634 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: None OUS: China
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 29, 2025
- Recall initiation date
- Dec 2, 2024
- Center classification date
- Jan 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.