Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
FDA Recall Z-0990-2025 · Posted 2025-01-17
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Recalling FirmMICROVENTION INC.
Recall StatusOpen, Classified
Product CodeDQY
Date Initiated2024-12-02
Product Quantity107 units
Reason for Recall
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Firm Action
On December 11, 2024, MicroVention Eurpose SARL dba Terumo Neuro intiated a "Urgent Medical Device Recall" via mail. Terumo Neuro asked consignees to take the following actions:
1. Review Inventory
2. Inform and forward recall notice
3. Return Product
4. Contact Quality Department
5. Replacement or Credit of returned devices
6. Adverse reaction or quality problems experienced with the use of this product may be reported to your local MicroVention Terumo Sales Representative or the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Root Cause
Packaging process control
Distribution Pattern
US: None OUS: China
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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