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Lower risk Medical device recall · FDA · Published November 22, 2019

Microvention HydroSoft 10 Coil Recall: Missing Implant Coil Risk

Microvention recalls HydroSoft 10 and HydroCoil Embolic Systems with missing implant coils. Affected units have specific Rx/REF numbers. Contact Microvention for details.

🇺🇸 FDA recall #Z-1392-2020Medical deviceMicrovention ›
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Recalling firmMicrovention, Inc.35 Enterprise · Aliso Viejo, CA 92656-2601
✎ GovInfoNow plain-language explainer

Microvention is recalling certain endovascular embolization coils that may be missing the implant coil. This could lead to improper treatment of vascular malformations or aneurysms. Read more at govinfonow.com/recall/66440-microvention-hydrosoft-10-coil-recall-missing-implant-coil-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66440-microvention-hydrosoft-10-coil-recall-missing-implant-coil-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1392-2020

Cite this page

“Microvention HydroSoft 10 Coil Recall: Missing Implant Coil Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66440-microvention-hydrosoft-10-coil-recall-missing-implant-coil-risk. Based on FDA recall #Z-1392-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1392-2020%22&limit=1).

The FDA announced on Nov. 22, 2019, that Microvention Inc. voluntarily recalled MicroVention Terumo HydroSoft 10 and HydroCoil Embolic System devices because they may be missing the implant coil. The recall affects 2,762 units distributed overseas.

How to tell if you have it

  • Brand: Microvention
  • Product names: MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical
  • REF numbers: 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 100152H2HS-V; 100153H2HS-V; 100154H2HS-V; 100201H2HS-V; 100202H2HS-V; 100203H2HS-V; 100204H2HS-V; 100206H2HS-V, 100208H2HS-V, 100254H2HS-V, 100256H2HS-V, 100304H2HS-V; 100306H2HS-V; 100308H2HS-V; 100310H2HS-V; 100404H2HS-V; 100406H2HS-V, 100408H2HS-V, 100410H2HS-V, 100506H2HS-V, 100508H2HS-V; 100510H2HS-V, 100515H2HS-V, 100520H2HS-V, 100620H2HS-V, and MV-00208HHSA
  • Distribution: 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

The hazard

The devices may be missing the implant coil. The firm name on the label is MicroVention, Inc., Tustin, CA.

Context

GovInfoNow's records show Microvention Inc. has 15 other recalls on record since Aug. 7, 2017. Other recent recalls of similar products include Microvention Bobby Balloon Guide Catheter Recall (April 30, 2026), Microvention LVIS Stent Device Recall (April 6, 2026), and Microvention Flow Re-Direction Devices (Sept. 5, 2025). Other recent recalls of similar products include ConMed Suture Anchor Recall (July 14, 2026), Micro Therapeutics Pipeline Flex Embolization Device (June 8, 2026), and Boston Scientific FARADRIVE Steerable Sheath Recall (June 11, 2026).

How to tell if you have this one

Check for Rx/REF numbers on the label: 100101H2HS-V through 100620H2HS-V and MV-00208HHSA. Also look for specific lot numbers like 1903135UR or 1904175WR.

  • Brand
    Microvention
  • Category
    Medical device
FDA recall event · 16 products

All 16 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    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.
Recall numberProduct, codes & lotsQuantity
Z-1392-2020MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 100152H2HS-V; 100153H2HS-V; 100154H2HS-V; 100201H2HS-V; 100202H2HS-V; 100203H2HS-V; 100204H2HS-V; 100206H2HS-V, 100208H2HS-V, 100254H2HS-V, 100256H2HS-V, 100304H2HS-V; 100306H2HS-V; 100308H2HS-V; 100310H2HS-V; 100404H2HS-V; 100406H2HS-V, 100408H2HS-V, 100410H2HS-V, 100506H2HS-V, 100508H2HS-V; 100510H2HS-V, 100515H2HS-V, 100520H2HS-V, 100620H2HS-V, and MV-00208HHSA - Product Usage: The HES 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.; Catalog/lot numbers: 100101H2HS-V - 1903135UR, 1903185UR, 1903225UR, and 1904035UR; 100102H2HS - V -1903135UR, 1903155UR, 1903155ZR, 1903185UR, 1903205UR, 1904035UR, 1904055UR, 1904085UR, 1904105UR,1904155UR, 1904175UR, 1904175ZR, and 1904245UR; 100103H2HS-V - 1903015UR, 1903045UR, 1903065UR, 1903085UR, 1903135UR, 1903205UR 1904055UR, 1904085UR, 1904155UR, 1905085UR, 1905105UR, 1905135UR, and 1905155UR; 100104H2HS-V - 1903015UR, 1903135UR, 1903205UR, 1904085UR, 1904105UR, and 1904155UR; 100151H2HS-V - 1903085UR, 1903185UR, and 1904015UR; 100152H2HS-V - 1903135UR, 1903155UR, 1903205NR, 1903205UR, 1904035UR, 1904055UR, 1904085UR, 1904105UR, 1904155UR, 1904175UR, 1904225UR, 1904245UR, 1904265UR, 1904295UR, 1905025UR, 1905035UR, 1905065UR, 1905085UR, 1903045WR, 1903185WR, 1903205WR, 1904105WR, 1904175WR, 1904225WR, 1905065WR, and 1905175WR; 100153H2HS-V - 1903015UR, 1903065UR, 1903085UR, 1903185UR, 1904015UR, 1904015ZR, 1904105UR, 1904155UR, 1904245UR, 1904265UR, and 1904295UR; 100154H2HS-V - 1903135UR, 1903155UR, 1903205UR, 1903225UR, 1904015UR, 1904035UR, 1904055UR, 1904085UR, 1904105UR, 1904155UR, 1904175UR, 1904225UR, 1904245UR, 1904265UR, 1904295UR, 1905025UR, 1905035UR, 1905065NR, 1905065UR, 1905155NR, 1903185WR, 1903205WR, 1904105WR, 1904225WR, and 1905065WR; 100201H2HS-V - 1905105PR; 100202H2HS-V - 1903155UR, 1904105UR, 1903185WR, 1903205WR, 1904175WR, 1905065WR, 1905135WR, and 1905155WR; 100203H2HS-V - 1903015UR, 1904015ZR, 1904105UR, 1904155UR, 1904175UR, 1904225UR, 1905025UR, 1905035NR, 1905035UR, 1905065UR, 1905085UR, 1905135NR, 1905155NR, 1903185WR, and 1905035WR; 100204H2HS-V - 1903015UR, 1903065UR, 1903085UR, 1904035UR, 1904155UR, 1904175UR, 1904175ZR, 1904225UR, 1904245UR, 1904245ZR, 1904265UR, 1904295UR, 1905025UR, 1905035NR, 1905035UR, 1905065UR, 1905085UR, 1905135NR, 1905155NR, 1904105WR, 1904175WR, 1905035WR, 1905065WR, 1905085WR, 1905135WR, and 1905155WR; 100206H2HS-V - 1903045UR, 1903065UR, 1903205UR, 1903225UR, 1904035UR, 1904055UR, 1904085UR, 1904105UR, 1904155UR, 1904175UR, 1904225UR, 1904245UR, 1904265UR, 1904295UR, 1905025UR, 1905035UR, 1905065NR, 1905065UR, 1905085UR, 1905105UR, 1905135UR, 1903185WR, 1904225WR, 1905065WR, 1905105PR, and 1905135WR; 100208H2HS-V - 1903015UR, 1903045UR, 1903085UR, 1903205UR, 1903225UR, 1904015UR 1904035UR, 1904175ZR, 1904225UR, 1904245UR, 1904265UR, 1904295UR, 1905025UR, 1905035UR, 1905065UR, 1905085UR, 1905105UR, 1905135UR, and 1905085WR; 100254H2HS-V - 1904245NR, 1903185WR, and 1905065WR; 100256H2HS-V - 1905065WR; 100304H2HS-V - 1903065WR, 1903205WR, and 1904225WR; 100306H2HS-V - 1903065UR, 1903085UR, 1904155UR, 1904175UR, 1904225UR, 1905135NR, 1905035WR, 1905065WR, 1905105PR, 1905135WR, and 1905155WR; 100308H2HS-V - 1904015UR, 1904155UR, 1904175UR, 1904225UR, 1904265UR, 1904295UR, 1905025UR, 1905065NR, 1905085UR, 1905105UR, 1905135NR, 1905155NR, 1903065WR, 1903185WR, 1903205WR, 1905065WR, 1905105WR, 1905155WR, and 1905225WR; 100310H2HS-V - 1903135UR, 1903155UR, 1903185UR, 1903205UR, 1904015UR, 1904035UR, 1904055UR, 1904085UR, 1904155UR, 1904175UR, 1904175ZR, 1904225UR, 1904245UR, 1904295UR, 1905085WR, and 1905225WR; 100404H2HS-V - 1904175WR, 1904225WR, 1905035WR, 1905065WR, and 1905155WR; 100406H2HS-V - 1903205WR, 1904175WR, and 1905035WR; 100408H2HS-V - 1903085UR, 1903135UR, 1903155UR, 1903155ZR, 1903185UR, 1903225UR,1904015UR, 1904035UR, 1904055UR, 1904225UR, 1903155PR, 1903205WR, 1904105WR, 1904245WR, and 1905065WR; 100410H2HS-V - 1903115UR, 1903155UR, 1903205UR, 1904155UR, 1904175UR, 1904225UR, 1903045WR, and 1905085WR; 100506H2HS-V - 1905155WR; 100508H2HS-V - 1903205WR; 100510H2HS-V - 1903045WR, 1905085WR, and 1905225WR; 100515H2HS-V - 1903065WR, 1903225W6, 1904175WR, 1905085WR, and 1905225WR; 100520H2HS-V - 1904155WR, 1904175WR, 1905085WR, and 1905225WR; 100620H2HS-V - 1903045WR, 1904175WR, 1904225WR, 1905085WR; and MV-00208HHSA - 1904175YR, 1905065XR, and 1905085YR.2,762 units
Z-1393-2020MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 100202HS3D-V, 100203HS3D-V, 100204HS3D-V, 100206HS3D-V, 100208HS3D-V, 100254HS3D-V, 100256HS3D-V, 100304HS3D-V, 100306HS3D-V, 100310HS3D-V, 100355HS3D-V, 100358HS3D-V, 100406HS3D-V, 100408HS3D-V, 100412HS3D-V, 100415HS3D-V, 100510HS3D-V, 100515HS3D-V; MV-00102HTDA, MV-00103HTDA, MV-00204HTDA,MV-00304HTDA, MV-00306HTDA, MV-00406HTDA, MV-00408HTDA, MV-00510HTDA, MV-01502HTDA, MV-01503HTDA, MV-01504HTDA; MV-02504HTDA, MV-02506HTDA, MV-03505HTDA, and MV-03508HTDA. 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.; Catalog/lot numbers: 100102HS3D-V - 1903045WT, 1903065WT, 1903205WT, 1904015WT, 1904035WT, 1904245WT, 1904255WT, 1904265WT, 1904295WT, 1905025WT, 1905065WT, 1905085WT, 1905155WT, 1905175WT, and 1905205WT; 100103HS3D-V - 1903115TT, 1903015WT, 1903085WT, 1903135WT, 1904015WT, 1904035WT, 1904055WT, 1904105WT, 1904265WT, 1904295WT, 1905035WT, 1905105PT, 1905135WT, 1905155WT, and 1905225WT; 100152HS3D-V - 1903065NT, 1903045WT, 1903085WT, 1903205WT, 1903225WT, 1904015WT, 1904105WT, 1904175WT, 1904295WT, 1905025WT, 1905105WT, 1905135WT, 1905155WT, and 1905175WT; 100153HS3D-V - 1903015WT, 1903045WT, 1903065WT, 1903155WT, 1904015WT, 1904035WT, 1904265WT, 1904295WT, 1905135WT, and 1905205WT; 100154HS3D-V - 1903045WT, 1903085WT, 1903135WT, 1903185WT, 1903225WT, 1904015WT, 1904035WT, 1904085WT, 1904105WT, 1904155WT, 1904175WT, 1904225WT, 1905025WT, 1905135WT, 1905155PT, 1905155WT, 1905175WT, and 1905205WT; 100202HS3D-V - 1903015WT, 1903065WT, 1903185WT, 1903205WT, 1905105WT, and 1905205WT; 100203HS3D-V - 1904015WT, 1904035WT, 1904265WT, 1904295WT, 1905065WT, 1905085WT, 1905155WT, and 1905225PT; 100204HS3D-V - 1903015WT, 1903045WT, 1903065WT, 1903085WT, 1904035WT, 1904055WT, 1904085WT, 1904245WT, 1904255WT, 1904295WT, 1905035WT, 1905065WT, and 1905085WT; 100206HS3D-V - 1904175WT, 1904225WT, 1904245WT, 1905105WT, 1905155PT, and 1905155WT; 100208HS3D-V - 1903085WT, 1903155WT, 1904035WT, 1905155PT, and 1905155WT; 100254HS3D-V - 1903015WT, 1903065WT, 1904015WT, 1904035WT, 1904055WT, 1904155WT, 1904225WT, 1904245WT, 1905035PT, 1905065WT; 100256HS3D-V - 1903015WT, 1903045WT, 1903065WT, 1903085WT, 1904015WC, 1904015WT, 1904035WT, 1904175WT, 1904245WT, 1904255WT, 1904265WT, 1904295WT, 1905035WH, 1905035WT, 1905155PT, and 1905225WT; 100304HS3D-V - 1903065WT, 1903115WT, 1903155WT, 1903205WT, 1904015WT, 1904055WT, 1904255WT, 1905105WT, 1905175WT, and 1905205WT; 100306HS3D-V - 1903085NT, 1903015WT, 1903085WT, 1903115WT, 1903135WT, 1903155WT, 1904015WT, 1904035WT, 1904055WT, 1904085WT, 1904225PT, 1904225WT, 1904245WT, 1904255WT, 1904265WT, 1905135WT, 1905175WT, and 1905205WT; 100310HS3D-V - 1903085WT and 1904035WT; 100355HS3D-V - 1903045WT, 1903085WT, 1904015WT, 1904225PT, 1904225WT, and 1905175WT; 100358HS3D-V - 1903065WT, 1904255WT, 1904265WT, 1904295WT, 1905035WT, 1905065WT, 1905085WT, 1905155WT, and 1905175WT; 100406HS3D-V - 1903015WT, 1903115WT, 1903205WT, 1904015WT, and 1905205WT; 100408HS3D-V - 1905205NT,1903085WT, 1903205WT, 1904015WT, 1904035WT, 1904055WT, 1904175WT, 1904225PT, 1904225WT, 1904255WT, 1904265WT, 1904295WT, 1905025WT, 1905105WT, 1905155WT, and 1905175WT; 100412HS3D-V - 1903135WT, 1904035WT, 1904175WT, and 1905105WT; 100415HS3D-V - 1903135WT, 1904035WT, 1905105WT, and 1905155WT; 100510HS3D-V - 1903065WT, 1904015WT, 1904035WT, 1904245WT, 1905105WT, and 1905155WT; 100515HS3D-V - 1903085NT, 1903015WT, 1903045WT, 1903085WT, 1903185WT, 1903205WT, 1904015WT, 1904035WT, 1904175WT, 1904265WT, 1904295WT, 1905025WT, 1905035WT, 1905085WT, 1905175WT; MV-00102HTDA - 1903015YT, 1903045YT, 1903155XT, 1904105YT, and 1904155XT; MV-00103HTDA - 1903045YT, 1903185YT, 1905065YT, and 1905085YT; MV-00204HTDA - 1904085YT and 1905065YT; MV-00304HTDA - 1905085YT; MV-00306HTDA - 1903015YT, 1903155XT, and 1903155YT; MV-00406HTDA - 1903015YT, 1904055YT, 1905065YT, and 1905085YT; MV-00408HTDA - 1903155YT, 1904015XT, 1904085YT, 1905035XT, 1905065YT, and 1905085YT; MV-00510HTDA - 1904085YT and 1905085YT; MV-01502HTDA - 1903015YT, 1904085YT, 1904105YT, 1905085YT, and 1905105YT; MV-01503HTDA - 1904055YT, 1904085YT, 1905085YT, 1905105XT, and 1905135YT; MV-01504HTDA - 1904085YT, 1904105YT, 1905085YT, 1905105XT, 1905105YT, 1905135YT, and 1905155YT; MV-02504HTDA - 1903155YT, 1904055YT, and 1905085YT; MV-02506HTDA - 1903155YT, 1905085YT, and 1905105YT; and MV-03505HTDA - 1903015YT, 1903155YT, 1904085YT, 1905085YT, and 1905105YT; and MV-03508HTDA - 1904055YT, 1904085YT, 1905085YT, and 1905105XT.1,725 units
Z-1394-2020MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620HC-R-V, 100620HCSR-R-V, 100730HC-R-V, 100730HCSR-R-V, 100830HC-R-V, 100930HC-R-V, 100930HCSR-R-V, 101030HC-R-V, and 101030HCSR-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.; Catalog/lot numbers: 100515HC-R-V - 1903135RL, 1905135RL, 1903115LL, 1903135LL, 1903155LL, 1903225LL, 1904015LL, 1904175LL, 1905025LL, 1905035LL, 1905065LL, and 1905085LL; 100515HCSR-R-V - 1903225UL, 1904245UL, 1903045WL, 1903115WL, 1904015PL, 1904225WL, 1905065WL, and 1905225WL; 100520HC-R-V - 1905175LL, 1905205LL, 1905205VL; 100520HCSR-R-V - 1904245UL, 1904295UL, and 1903085WL; 100620HC-R-V - 1903115LL, 1905035LL, and 1905065LL; 100620HCSR-R-V - 1904245UL; 100730HC-R-V - 1905155LL, 1905175LL, and 1905225LL; 100730HCSR-R-V - 1904175PL, 1904225WL, and 1905035WL; 100830HC-R-V - 1905135RL, 1905135LL, and 1905175LL; 100930HC-R-V - 1903115LL; 100930HCSR-R-V - 1903085ZL, 1903115UL, 1903135UL, and 1904245UL; 101030HC-R-V - 1903135RL; and 101030HCSR-R-V - 1904245UL and 1903015RL.486 units
Z-1395-2020MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, 100410HCSR-S-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.; Catalog/lot numbers: 100206HCSR-S-V - 1903225UH, 1904055UH, 1904085UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905225UH, 1903015WL, 1903205WL, 1904295WL, 1905035WL, and 1905175PL; 100208HC-S-V - 1904035RL, 1904155LL, 1905035LL, 1905065LL, and 1905065VL 100208HCSR-S-V - 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1903085RL, 1903015WL, and 1903065WL; 100306HCSR-S-V - 1903085WL and 1904015PL; 100308HCSR-S-V - 1904105UH, 1904155UH, 1903015PL, 1903015WL, 1903045WL, 1903085WL, 1903185WL, 1905135WL, and 1905175PL; 100310HC-S-V - 1903045VL, 1904155LL, 1905035LL, 1905065LL, and 1905155LL; 100310HCSR-S-V - 1904245UL, 1904265UL, 1903015WL, 1903085WL, and 1903185WL; 100410HC-S-V - 1904155LL, 1904175LL, 1905035LL, 1905065LL, and 1905135RL; and 100410HCSR-S-V - 1904105UL, 1903015WL, 1903085WL, and 1903185WL.780 units
Z-1396-2020MicroVention 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.; Catalog/lot numbers: 180520HC-R-V - 1903135RE; and 181230HC-R-V - 1903085RE.9 units
Z-1397-2020MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S-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.; Catalog/lot numbers: 180204HC-S-V - 1903185WE and 1905105WE; 180208HC-S-V - 1904175PE, 1904175WE, 1904225WE, 1904265WE, 1904295WE, 1905025WE, 1905065PE, 1905065WE, 1905085WE, 1905175WE, 1905225WE; 180308HC-S-V - 1904225WE, 1904265WE, 1905025WE, and 1905035WE; 180410HC-S-V - 1903185WE, 1904015PE, 1904265WE, 1904295WE, 1905085WE, and 1905175WE; and 180512HC-S-V - 1903185WE, 1904265WE, 1904295WE, 1905085PE, 1905085WE, 1905155PE, 1905155WE, and 1905225WE.169 units
Z-1398-2020MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 100515CSSR-V, 100522CSSR-V, 100618CSSR-V, 100626CSSR-V, 100722CSSR-V, 100731CSSR-V, 100825CSSR-V, 100837CSSR-V, 100933CSSR-V, and 101036CSSR-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.; Catalog/lot numbers: 100202CSSR-V - 1903155ZC, 1903185UC, 1903225UC, 1904085UC, 1904225NC, 1905155ZC, 1905205UC, 1905205ZC, 1905225UC, 1903015WC, 1903045WC, 1903065WC, 1903085WC, 1904015WC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1905065WC, 1905085WC, 1905105WC, 1905175WC, 1905205WC, and 1905225WC; 100254CSSR-V - 1904105UC, 1904155UC, 1904175UC, 1904225ZC, 1904245UC, 1905025UC, 1905035UC, 1905065UC, 1905105UC, 1905135UC, 1905155UC, 1905175UC, 1905205UC, 1903015WC, 1904015WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, 1905175WC, and 1905225WC; 100306CSSR-V - 1903045UC, 1903065UC, 1903085UC, 1903115UC, 1903135UC, 1903155ZC, 1903185UC, 1903205UC, 1903225UC, 1904035RC, 1904105UC, 1904155UC, 1904175UC, 1904225UC, 1904245UC, 1904265UC, 1904295UC, 1905035UC, 1905065UC, 1905085UC, 1905105UC, 1905105ZC, 1905135UC, 1905155UC, 1905175UC, 1905205UC, 1905205ZC, 1905225UC, 1903015WC, 1903045WC, 1903065WC, 1903205WC, 1904015WC, 1904055WC, 1904085WC, 1904225PC, 1904225WC, 1904245WC, 1904245WH, 1904245WT, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905105WC, 1905155PC, and 1905205WC; 100408CSSR-V - 1903065UC, 1904015UC, 1904035RC, 1904035UC, 1904055UC, 1904055ZC, 1904085UC, 1903015WC, 1904015WC, 1904035WC, 1904155WC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905155WC, and 1905175WC; 100412CSSR-V - 1903185UC, 1903205UC, 1903225UC, 1905085UC, 1905105ZC, 1905135UC, 1905225UC, 1903045WC, 1903085WC, 1903205WC, 1903225WC, 1904175PC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905155WC, 1905175WC, 1905205WC, and 1905225WC; 100515CSSR-V - 1903185UC, 1903205UC, 1904035RC, 1904155UC, 1904175UC, 1904225UC, 1904225ZC, 1904245UC, 1904265UC, 1905025UC, 1905035UC, 1905065UC, 1905085UC, 1905105UC, 1905135UC, 1905155UC, 1905205UC, 1905225UC, 1905225ZC, 1903015WC, 1903065WC, 1903085WC, 1903185WC, 1903205WC, 1904015WC, 1904035WC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, and 1905225WC; 100522CSSR-V - 1904155UC, 1904175UC, 1904225UC, 1904245UC, 1903045WC, 1903065WC, 1903085WC, 1904015WC, 1904055WC, 1904175WC, 1904245WC, 1904265WC, 1904295WC, 1905035WC, 1905065WC, 1905155WC, 1905175WC, and 1905205WC; 100618CSSR-V - 1903205LC, 1905155LC, 1905205LC, 1905205VC, 1903045WC, 1903085WC, 1903185WC, 1904175WC, 1904225WC, 1904245WC, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, and 1905225WC; 100626CSSR-V - 1903015LC, 1903045WC, 1903065WC, 1903205WC, 1904015WC, 1904295WC, 1905065WC, 1905085WC, and 1905205WC; 100722CSSR-V - 1903015WC, 1903065WC, 1903185WC, 1904015WC, 1904175WC, 1904265WC, 1904295WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, and 1905175WC; 100731CSSR-V - 1903015WC, 1903045WC, 1903065WC, 1905085WC, 1905105WC, 1905155WC, and 1905205PC; 100825CSSR-V - 1903015WC, 1903045WC, 1904015WC, 1904105WC, 1904175PC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905085WC, 1905155PC, and 1905175WC; 100837CSSR-V - 1903015WC, 1903065WC, 1903085WC, 1904015WC, 1905105WC, 1905135WC, and 1905205WC; 100933CSSR-V - 1905135RC, 1903015WC, 1903045WC, 1903065WC, 1903085WC, 1904015WC, 1904265WC, 1905105WC, 1905175WC, and 1905225WC; and 101036CSSR-V - 1903015WC, 1903065WC, 1903085WC, 1903115WC, 1903205WC, 1905155WC, and 1905225WC.3,442 units
Z-1399-2020MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451CS-V, 181652CS-V, 181859CS-V, 182065CS-V, 182263CS-V, and 182468CS-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.; Catalog/lot numbers: 180619CS-V - 1903065W1, 1904015P1, 1904225W1, 1904295W1, 1905085P1, 1905085W1, 1905175W1, and 1905205W1; 180723CS-V - 1903085W1, 1903185W1, 1904015P1, 1904175P1, 1904295W1, 1905085W1, and 1905175W1; 180827CS-V - 1903205W1, 1904015P1, 1905155W1, and 1905205W1; 180931CS-V - 1904225R1, 1903205W1, 1905175W1, and 1905225W1; 181036CS-V - 1904035R1, 1903085W1, 1903185W1, 1904225W1, 1904265W1, 1905035W1, 1905065W1, 1905175W1, and 1905205W1; 181139CS-V - 1903015L1, 1903015W1, 1903085P1, 1903085W1, 1903185W1, 1904015P1, 1904245P1, and 1904245W1; 181243CS-V - 1903015L1, 1903015W1, 1903065W1, 1903185W1, 1904015P1, 1904175P1, 1904225W1, 1904265W1, 1904295W1, 1905155W1, 1905175W1, and 1905225W1; 181347CS-V - 1903085V1, 1903135R1, 1904035R1, 1903015W1, 1903085W1, 1903205P1, 1903205W1, and 1904225W1; 181451CS-V - 1903085W1, 1903225W1, 1904015P1, 1904175P1, 1904225W1, 1904295W1, 1905105W1, and 1905135W1; 181652CS-V - 1905135R1, 1903015W1, 1903045W1, 1903085W1, 1903205W1, 1903225W1, 1904105W1, 1905105W1, and 1905225W1; 181859CS-V - 1903155P1, 1903155W1, 1903185H1, and 1905105W1; 182065CS-V - 1903045L1, 1904085Q1, 1903155W1, 1903185H1, and 1903205H1; 182263CS-V - 1904035R1; and 182468CS-V - 1903015L1, 1903135R1, 1904055R1, 1905205R1, 1904295H1, 1905025G1, 1905025H1, 1905105H1, 1905105W1, 1905135H1, and 1905205H1.403 units
Z-1400-2020MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100820CC-V, 100924CC-V, and 101026CC-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.; Catalog/lot numbers: 100204CC-V -1905085LX, 1905175LX, 1905205LX, 1903185WX, 1903205WX, 1904225WX, 1904245WX, 1904265WX, and 1904295WX; 100307CC-V - 1903205WX, 1904015WX, 1904225WX, 1904245WX, 1904265WX, and 1905225WX; 100410CC-V - 1904015WX, 1904175PX, 1904175WX, 1904225WX, 1904245WX, 1904265WX, 1905025WX, 1905065WX, 1905155WX, 1905205WX, and 1904035QX; 100512CC-V - 1903115LX, 1905205LX, 1903045WX, 1903205PX, 1903205WX, 1904225WX, 1905175WX, 1905205WX, 1904225RX, and 1905135RX; 100615CC-V - 1903085WX, 1903205WX, 1904225WX, 1904265WX, 1905105WX, 1905175WX, and 1905225PX; 100718CC-V - 1903115LX, 1905175LX, 1905205LX, 1903185WX, 1903205WX, 1904225WX, 1904265WX, 1905105WX, and 1905175WX; 100820CC-V - 1905175LX, 1904175WX, 1905025WX, 1905065PX, and 1905135RX; 100924CC-V - 1905175LX, 1904175WX, 1905065PX, 1905155WX, and 1904225RX; and 101026CC-V - 1905105LX, 1905175LX, 1905205LX, 1904175WX, 1904225WX, and 1905065PX.409 units
Z-1401-2020MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-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.; Catalog/lot numbers: 180512CC-V - 1905205W3; 180820CC-V - 1903115L3; 181026CC-V - 1903115L3; 181434CC-V - 1903115L3, 1905155W3, and 1905205R3; and 182050CC-V - 1905205W3, 1903115L3, 1903115L3, 1903115L3, 1905155W3, and 1905205R3.19 units
Z-1402-2020MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V, 100510HFRM-V, 100515HFRM-V, 100519HFRM-V, 100612HFRM-V, 100619HFRM-V, 100623HFRM-V, 100715HFRM-V, 100728HFRM-V, 100817HFRM-V, 100833HFRM-V, 100931HFRM-V; 101036HFRM-V, MV-00408HHFA, MV-00510HHFA, MV-00515HHFA, and MV-00619HHFA. Product Usage: The HES 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.; Catalog/lot numbers: 100306HFRM-V - 1903135WF, 1903155WF, 1903015UF, 1903065UF, 1903065ZF, 1903085UF, 1903135UF, 1903155NF, 1903205UF, 1904015UF, 1904035UF, 1904155UF, 1904175UF, 1904225UF, 1904245UF, 1904265UF, 1905085UF, 1905105UF, 1905135UF, 1905155UF, and 1905175UF; 100405HFRM-V - 1903015WF, 1903085WF, 1904225PF, and 1905155WF; 100408HFRM-V - 1903015WF, 1903065WF, 1903085WF, 1903155WF, 1903225WF, 1904225PF, 1905155WF, 1903015UF, 1903135UF, 1903205UF, 1903225UF, 1904175UF, 1904225UF, 1904245UF, 1904265UF, 1904295UF, 1905025UF, 1905085UF, 1905135UF, and 1905155UF; 100410HFRM-V - 1903085WF and 1904055WF; 100412HFRM-V - 1903205UF, 1903225UF, 1904015UF, 1904035UF, 1904055UF, 1904155UF, 1904175UF, 1904225UF, 1904245UF, 1904265UF, 1904295UF, 1905155UF, 1905205UF, and 1905225UF; 100415HFRM-V - 1904105WF, 1904225PF, and 1905035WF; 100510HFRM-V - 1903015WF, 1903185WF, 1904175WF, 1905155WF, and 1905205RF; 100515HFRM-V - 1903015WF, 1903085WF, 1903185WF, 1904105WF, 1904175WF, 1904225PF, 1904225WF, 1904245WF, 1905085WF, 1903085UF, 1903135UF, 1903155UF, 1903205UF, 1903225UF, 1904015UF, 1904035UF, 1904055UF, 1904175UF, 1904175ZF, 1904225UF, 1904245UF, 1904265UF, 1904295UF, 1905085UF, 1905105UF, 1905135UF, 1905155UF, and 1905225UF; 100519HFRM-V - 1905155UF; 100612HFRM-V - 1903185WF, 1903225WF, and 1905205WF; 100619HFRM-V - 1903065WF, 1903185WF, 1903225WF, 1905155WF, 1903085UF, 1903155UF, 1903225UF, 1904155UF, 1904175UF, 1904225UF, and 1904245UF; 100623HFRM-V - 1903115UF; 100715HFRM-V - 1903045WF, 1903115WF, 1903135WF, 1903185WF, and 1903155QF; 100728HFRM-V - 1903015WF, 1903085WF, 1905155WF, and 1904225UF; 100817HFRM-V - 1903045WF, 1903135WF, and 1905155WF; 100833HFRM-V - 1903015WF, 1903045WF, 1903085WF, 1905155WF, 1905205WF, 1904055UF, and 1904225UF; 100931HFRM-V - 1903085WF, 1903185WF, 1904225PF, 1905155WF, 1903205UF, 1904015UF, 1904035UF, 1904265UF, and 1904295UF; 101036HFRM-V - 1903015WF, 1904225PF, 1905155WF, and 1904175UF; MV-00408HHFA - 1905175YF; MV-00510HHFA - 1905105YF; MV-00515HHFA - 1905175YF and 1905205YF; and MV-00619HHFA - 1905035YF and 1905175YF.991 units
Z-1403-2020MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. Product Usage: The HES 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.; Catalog/lot numbers: 180723HFRM-V - 1904175P7 and 1904175W7; 180931HFRM-V - 1904225P7 and 1904225W7; 181644HFRM-V - 1905025W7 and 1905155W7; MV-80619HHFA - 1904175X7, 1904175Y7,1905065X7, and 1905085Y7; MV-80827HHFA - 1904175X7, 1904225Y7, and 1905065X7; MV-80931HHFA - 1905065X7; and MV-81036HHFA - 1904175Y7.32 units
Z-1404-2020MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 100612CMSR-V, 100618CMSR-V, and 100721CMSR-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.; Catalog/lot numbers: 100203CMSR-V - 1903085WP; 100408CMSR-V - 1903085WP and 1904015PP; 100412CMSR-V - 1904225RP, 1905205QP, and 1904035PP; 100510CMSR-V - 1905205QP and 1904085WP; 100516CMSR-V - 1903135WP and 1905155WP; 100612CMSR-V - 1903225WP; 100618CMSR-V - 1903135QP and 1904085WP; and 100721CMSR-V - 1903085RP.85 units
Z-1405-2020MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202HHTA, MV-00203HHTA, MV-00204HHTA, MV-00206HHTA, MV-00208HHTA, MV-00304HHTA, MV-00306HHTA, MV-00308HHTA, MV-00310HHTA, MV-00408HHTA, MV-00412HHTA, MV-00510HHTA, MV-00515HHTA, MV-00612HHTA, MV-00619HHTA, MV-00715HHTA, MV-00728HHTA, MV-00817HHTA, MV-00833HHTA, MV-01502HHTA, MV-01503HHTA, MV-01504HHTA, MV-02504HHTA, MV-02506HHTA, and MV-02508HHTA. Product Usage: The HES 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.; Catalog/lot numbers: 100102HFRM-V - 1903045W6 and 1903135W6; 100152HFRM-V - 1903085W6, 1903185P6, and 1903185W6; 100153HFRM-V - 1903135W6; 100154HFRM-V - 1903015W6, 1903205W6, 1903225W6, 1904225P6, and 1904225W6; 100202HFRM-V - 1903065W6, 1903085W6, and 1903135W6; 100206HFRM-V - 1903065W6 and 1903085W6; 100208HFRM-V - 1903065W6; 100254HFRM-V - 1903045W6, 1903085W6, and 1903115W6; 100256HFRM-V - 1903045W6 and 1903225W6; 100308HFRM-V - 1903115W6, 1903155W6, and 1903205W6; MV-00202HHTA - 1903065Y6, 1903205Y6, and 1903225Y6; MV-00203HHTA - 1903085Y6, 1903225Y6, 1904155Y6, 1905085X6, 1905085Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00204HHTA - 1903085Y6, 1904155X6, 1904155Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905205Y6, and 1905225Y6; MV-00206HHTA - 1904015Y6, 1904155X6, 1905025Y6, 1905035Y6, 1905085Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00208HHTA - 1905135Y6, 1905205Y6, 1905225X6, and 1905225Y6; MV-00304HHTA - 1903065Y6, 1903135Y6, 1903205Y6, 1904035Y6, 1905025Y6, 1905065Y6, and 1905085Y6; MV-00306HHTA - 1903135Y6, 1903205Y6, 1903225Y6, 1904055Y6, 1904085Y6, 1904105Y6, 1905025Y6, 1905035Y6, 1905085Y6, 1905105Y6, and 1905135Y6; MV-00308HHTA - 1905085Y6, 1905205Y6, and 1905225Y6; MV-00310HHTA - 1905025Y6, 1905035Y6, 1905065Y6, 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00408HHTA - 1903225X6, 1904035Y6, 1905025Y6, and 1905035Y6; MV-00412HHTA - 1903115Y6, 1903135Y6, 1903205Y6, 1904035Y6, 1904055Y6, 1904085Y6, 1904105Y6, 1904225Y6, 1905025Y6, 1905035Y6, 1905065Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905175Y6, and 1905205Y6; MV-00510HHTA - 1903225Y6, 1904035Y6, 1904055Y6, 1905085Y6, 1905105Y6, 1905175Y6, and 1905225Y6; MV-00515HHTA - 1903225X6, 1904035Y6, 1905025Y6, 1905035Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905175X6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00612HHTA - 1903085Y6, 1903115Y6, 1903135Y6, 1903225X6, 1904055Y6, 1905025Y6, 1905035Y6, and 1905085Y6; MV-00619HHTA - 1903085Y6, 1903115Y6, 1903225Y6, 1904055Y6, 1905035Y6, 1905065Y6, 1905085Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00715HHTA - 1905065Y6, 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, 1905225X6, and 1905225Y6; MV-00728HHTA - 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00817HHTA - 1905105Y6, 1905175Y6, and 1905205X6; MV-00833HHTA - 1903085Y6, 1903205Y6, 1905035Y6, 1905085Y6, 1905135Y6, and 1905205Y6; MV-01502HHTA - 1903085Y6, 1903205Y6, 1905025Y6, 1905105Y6, 1905175Y6, and 1905205Y6; MV-01503HHTA - 1903085Y6, 1903115Y6, 1903135Y6, 1903205Y6, 1903225X6, 1903225Y6, 1904035Y6, and 1905035Y6; MV-01504HHTA - 1905035Y6, 1905065Y6, and 1905085Y6; MV-02504HHTA - 1903085Y6, 1903205Y6, 1905025Y6, 1905065Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-02506HHTA - 1903085Y6, 1903205Y6, 1905025Y6, 1905065Y6, 1905105Y6, 1905135Y6, 1905205Y6, and 1905225Y6; and MV-02508HHTA - 1905085Y6, 1905105Y6, 1905135Y6, 1905155Y6, 1905205Y6, and 1905225Y6.847 units
Z-1406-2020MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC030610-V, VFC030615-V, VFC061020-V, VFC061030-V, VFC101530-V, VFC101540-V, VFC152040-V, and VFC152060-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.; Catalog/lot numbers: MV-00306VFC - 1904105NZ and 1905085NZ; MV-00310VFC - 1903045TZ, 1904035TZ, 1904085NZ, AND 1905065NZ; MV-00315VFC - 1903045TZ, 1903155NZ, and 1904055YV; MV-00630VFC - 1904085FV and 1905085FV; VFC010303-V - 1903065WV, 1904015WV, 1904105WV, 1904155WV, 1904175WV, 1904225WV, 1904245WV, 1904265WV, 1905065WV, 1905105WV, 1905155WV, and 1905175WV; VFC030606-V - 1903045WV, 1903065WV, 1903085PV, 1903205WV, 1904015WV, 1904035WV, 1904055WV, 1904105WV, 1904155PV, 1904175UV, 1904175WV, 1904225WV, 1904245UV, 1904245WV, 1904265WV, 1905065WV, and 1905175WV; VFC030610-V - 1903015WV, 1903065WV, 1904015WV, 1904035WV, 1904055WV, 1904155WV, 1904175UV, 1904175WV, 1904225UV, 1904225WV, 1904245UV, 1904245WV, 1904265WV, 1905065WV, 1905085WV, 1905105WV, 1905135WV, 1905155PV, 1905175WV, and 1905225WV; VFC030615-V - 1903015WV, 1903045WV, 1903065PV, 1903065WV, 1903225UV, 1903225ZV, 1904015WV, 1904055WV, 1904085WV, 1904245WV, 1904265WV, 1905025WV, 1905035WV, 1905085PV, 1905085WV, and 1905175WV; VFC061020-V - 1903045WV, 1903065WV, 1903205WV, 1904225WV, 1904265WV, 1905025WV, 1905065WV, 1905085WV 1905175WV, and 1905225WV; VFC061030-V - 1903065WV, 1904015PV, 1904015WV, 1904055WV, 1904225WV, 1904245WV, 1904265WV, 1905035WV, 1905065PV, and 1903115RV; VFC101530-V - 1903135WV, 1904265WV, 1905025WV, 1905105WV, 1905175WV, and 1905205WV; VFC101540-V - 1903045WV, 1903185WV, 1904265WV, 1905025WV, 1905035WV, and 1905225WV; VFC152040-V - 1903135RV; and VFC152060-V - 1903085RV, 1904265RV, and 1905135RV.666 units
Z-1407-2020MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS-V, 100153HS-V, 100154HS-V, 100201HS-V, 100202HS-V, 100203HS-V, 100204HS-V, 100206HS-V, 100254HS-V, 100256HS-V, 100304HS-V, 100306HS-V, 100308HS-V, 100406HS-V, 100408HS-V, and 100508HS-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.; Catalog/lot numbers: 100101HS-V - 1903045UH, 1903065UH, 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1903225ZH, 1904085UH, 1904105UH, 1904175UH, 1904245UH, 1905025UH, 1905085UH, 1905105ZH, 1905135UH, 1905175UH, 1905205UH, 1905205ZH, 1905225UH, 1905225ZH, 1903135WH, 1904175WH, 1905085WH, 1905105PH, and 1905135WH; 100102HS-V - 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1903225ZH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, 1905205ZH, 1905225UH, 1905225ZH, 1904035WH, and 1905155WH; 100103HS-V - 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1904105UH, 1904155UH, 1904175UH, 1904225UH, 1904245UH, 1905025UH, 1905025ZH, 1905035UH, 1905035ZH, 1905065UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, and 1905085WH; 100104HS-V - 1903115UH, 1903135UH, 1903225UH, 1904085UH, 1904105UH, 1904155UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, 1904175WH, 1904225WH, and 1905155WH; 100151HS-V - 1905025UH, 1903135TH, 1903085WH, 1903205WH, 1904015WH, 1904265WH, 1904295WH, 1905085WH, 1905155WH, and 1905225PH; 100152HS-V - 1903155UH, 1903185UH, 1903205UH, 1904085UH, 1904105UH, 1904155UH, 1904225UH, 1904245UH, 1905025UH, 1905025ZH, 1905035UH, 1905035ZH, 1905065UH. 1905085UH, 1905105UH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205ZH, 1903065NH, 1904175TH, 1904225NH, 1905065NH, 1903015WH, 1903065WH, 1903185WH, 1904015WH, 1904035WH, 1904055WH, 1904085WH, 1904155WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035PH, 1905035WH, 1905065WH, 1905085WH, 1905155WH, and 1905225WH; 100153HS-V - 1903225UH, 1905105UH, 1905135UH, 1905135ZH, 1905155UH, 1905175UH, 1905205UH, 1905225UH, 1905225ZH, 1903015NH, 1903065WH, 1903085WH, 1903205WH, 1904015WH, 1904035WH, 1904055WH, 1904155WH, 1904175WH, 1904225PH, 1904225WH, 1904245WH, 1904265WH, 1905025WH, 1905035PH, 1905065WH, 1905085WH, 1905155WH, 1905205PH, 1905225PH, and 1905225WH. 100154HS-V - 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, 1905225UH, 1903115TH, 1903015WH, 1903045WH, 1903065WH, 1904035WH, 1904055WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905035PH, 1905035WH, 1905065WH, 1905085WH, 1905155PH, 1905155WH, 1905175WH, and 1905205WH; 100201HS-V - 1903135UH 100202HS-V - 1904085UH, 1904105UH, 1904175UH, 1904245UH, 1904225NH, 1905065NH, 1905205NH, 1903085WH, 1904015WH, 1904055WH, 1904175WH, 1904245WH, 1904265WH, 1904295WH, 1905085WH, 1905225PH, and 1905225WH; 100203HS-V - 1903155UH, 1903185UH, 1903225UH, 1904225NH, 1905135NH, 1903015WH, 1903065WH, 1904035WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905035WH, 1905155WH, and 1905225WH; 100204HS-V - 1904085UH, 1904105UH, 1904225UH, 1904245UH, 1905065UH, 1905085UH, 1905105UH, 1905135UH, 1905135ZH, 1905155UH, 1905175UH, 1905205UH, 1903045WH, 1903065WH, 1904015WH, 1904035WH, 1904155WH, 1904175WH, 1904225PH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035WH, 1905085WH, 1905155WH, and 1905225WH; 100206HS-V - 1904085UH, 1904105UH, 1904155UH, 1904175UH, 1904265UH, 1905065UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905175UH, 1905205UH 1905205ZH, 1905225UH, 1903065WH, 1903085WH, 1903185WH, 1904055WH, 1904175WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035PH, 1905035WH, 1905065WH, 1905155WH, 1905175WH, and 1905225WH; 100254HS-V - 1903205WH, 1904015WH, 1904225WH, 1904265WH, 1904295WH, 1905025WH, 1905085WH, and 1905225PH; 100256HS-V - 1903065WH, 1903185WH, 1904015WH, and 1905155WH; 100304HS-V - 1903085NH, 1903135TH, 1904035TH, 1903065WH, 1905035PH, and 1905065WH; 100306HS-V - 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1904085UH, 1903065WH, 1904035WH, 1904055WH, 1904155WH, 1904175WH, 1904225WH, 1904245WH, 1905035PH, 1905065WH, 1905205PH, and 1905225PH; 100308HS-V - 1903185UH, 1903225UH, 1905135UH, 1905175UH, 1905205UH, 1903085NH, 1903015WH, 1903065WH, 1903185WH, 1904015WH, 1904035WH, 1904055WH, 1904175WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035PH, 1905035WH, and 1905065WH; 100406HS-V - 1903085WH, 1903185WH, 1904035WH, 1904225WH, and 1905205WH; 100408HS-V - 1905085UH, 1905105UH, 1905135UH, 1905155UH, 1903115TH, 1903015WH, 1903065WH, 1904265WH, 1904295WH, 1905085WH, 1905135WH, 1905155WH, and 1905205PH; 100508HS-V - 1903225TH, 1905205NH, 1903015WH, 1903085WH, 1903135WH, 1903185WH, 1904265WH, 1905105WH, and 1905205WH.5,777 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the Rx/REF number on the device label to confirm if it's affected.

  2. Contact Microvention

    Reach out to Microvention for specific instructions on whether your device is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Nov 22, 201912. FDA classified it Class II: Feb 27, 202023. Published in FDA’s Enforcement Report: Mar 4, 202034. FDA terminated the recall: Jan 26, 2022420192022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Questions people ask

Are there any risks to patients?

The recall is for medical devices used in procedures; patients who received the coils during treatment may need to follow up with their healthcare provider.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1392-2020 (November 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1392-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA