Microvention — Class II medical device recall Z-0990-2025
Ongoing recall by MICROVENTION INC., reported 2025-01-29. Sterility assurance; microcatheter inner packaging may contain incomplete seal.
| Recall number | Z-0990-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MICROVENTION INC., Aliso Viejo, CA, United States |
| Recall initiated | 2024-12-02 |
| Classified | 2025-01-17 |
| Reported by FDA | 2025-01-29 |
| Countries outside the US | CN |
| Quantity | 107 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00816777027634 |
| Lot numbers | 0000629846 |
| Model numbers | MC172150SX-CN |
Product
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Reason for recall
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0990-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.