Home / Recalls / MICROVENTION INC. / Z-0990-2025

Z-0990-2025 Class II Ongoing

Recalled by MICROVENTION INC. — Aliso Viejo, CA

Recall Details

Product Type
Devices
Report Date
January 29, 2025
Initiation Date
December 2, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
107 units

Product Description

Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846

Reason for Recall

Sterility assurance; microcatheter inner packaging may contain incomplete seal.

Distribution Pattern

US: None OUS: China

Code Information

Lot # 0000629846/UDI: (01)00816777027634

Other recalls by MICROVENTION INC.

  • Z-0108-2026 Class II — Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED452 (September 5, 2025)
  • Z-2188-2025 Class II — LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 (May 29, 2025)
  • Z-1121-2025 Class II — MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 m (December 11, 2024)
  • Z-3157-2024 Class II — ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval (August 5, 2024)
  • Z-0868-2024 Class II — TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 (December 21, 2023)
  • Z-0187-2024 Class II — AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 (August 24, 2023)
  • Z-2238-2023 Class II — FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511 (June 7, 2023)
  • Z-0170-2023 Class II — WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm (September 21, 2022)
  • Z-0202-2022 Class II — Aspiration Syringe Kit, REF: MVSK60 (October 20, 2021)
  • Z-1830-2021 Class III — VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen ca (April 21, 2021)