Recall Z-0990-2025 ยท DQY Catheter, Percutaneous
MICROVENTION INC.
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
| Date | Jan 17, 2025 (initiated Dec 2, 2024) |
| Status | Open, Classified |
| Reason | Sterility assurance; microcatheter inner packaging may contain incomplete seal. |
| Root cause | Packaging process control |
| 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. |
| Quantity | 107 units |
| Distribution | US: None OUS: China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101542 | HEADWAY 17 ADVANCED MICROCATHETER MicroVention, Inc., Aug 6, 2010 |