FDA Device recall Z-0990-2025
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
- FDA Device
- Class II
- ongoing
- Published 2025-01-29
On 2025-01-29 the FDA classified a Class II recall of Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846 by Microvention, citing sterility assurance; microcatheter inner packaging may contain incomplete seal.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0990-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-02 |
| Published | 2025-01-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microvention |
| Distribution | n/a |
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.
Identifiers
| code_info | Lot # 0000629846/UDI: (01)00816777027634 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0990-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.