Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
This recall is currently active, issued January 17, 2025. It was issued by Microvention Inc..
- Company
- Microvention Inc.
- Recall Initiated
- December 2, 2024
- Posted
- January 17, 2025
- Recall Number
- Z-0990-2025
- Quantity
- 107 units
- Firm Location
- Aliso Viejo, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Distribution
US: None OUS: China
Lot / Code Info
Lot # 0000629846/UDI: (01)00816777027634
Root Cause
Packaging process control
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.