Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Recall
- Recall Number
- Z-0990-2025
- Event Number
- 95962
- Firm
- MICROVENTION INC.
- FEI Number
- 3013556777
- Product Code
- DQY
- Status
- Open, Classified
- Root Cause
- Packaging process control
- Initiated
- December 2, 2024
- Posted
- January 17, 2025
- Address
- 35 Enterprise, Aliso Viejo, CA, 92656
Description
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
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.
US: None OUS: China
107 units