Home / Recalls / Microvention, Inc. / Z-1396-2020

Z-1396-2020 Class II Terminated

Recalled by Microvention, Inc. — Aliso Viejo, CA

FDA device recall Z-1396-2020 was initiated by Microvention, Inc. on November 22, 2019 and is designated Class II. Reason for recall: The devices may be missing the implant coil. The recall status is terminated (terminated January 26, 2022). Affected quantity: 9 units.

Recall Details

Product Type
Devices
Report Date
March 4, 2020
Initiation Date
November 22, 2019
Termination Date
January 26, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 units

Product Description

MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520HC-R-V and 181230HC-R-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Reason for Recall

The devices may be missing the implant coil.

Distribution Pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

Code Information

Catalog/lot numbers: 180520HC-R-V - 1903135RE; and 181230HC-R-V - 1903085RE.

Other recalls by Microvention, Inc.

  • Z-2912-2026 Class II — BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL B (April 30, 2026)
  • Z-2200-2026 Class II — LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWork (April 6, 2026)
  • 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-0990-2025 Class II — Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coati (December 2, 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)

FDA data resources