Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx On
FDA device recall Z-0990-2025 · posted 2025-01-17 · Open, Classified
Recall details
- Recalling firm
- MICROVENTION INC.
- Reason for recall
- Sterility assurance; microcatheter inner packaging may contain incomplete seal.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- DQY
- Quantity affected
- 107 units
- Distribution
- US: None OUS: China
- Date initiated
- 2024-12-02
- Date posted
- 2025-01-17
- Location
- Aliso Viejo, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEADWAY 17 ADVANCED MICROCATHETER (K101542) | MicroVention, Inc. | 2010-08-06 |