Microvention, Inc.: MicroVention 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.

Recall number

Z-1392-2020

Recalling firm

Microvention, Inc.

Product

MicroVention 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.

Status

Terminated

Initiated

2019-11-22

Posted

not on file

Terminated

2022-01-26

Reason

The devices may be missing the implant coil.

Root cause

Process design

Action

The recalling firm issued letters beginning 11/22/2019 dated 11/26/2019 via email using different flags according to the region the foreign consignee was located, i.e. 'URGENT: FIELD SAFETY CORRECTION ACTION" (for EMEA), "URGENT: MEDICAL DEVICE RECALL" (for Japan), or "FIELD SAFETY ADVISORY NOTICE" (for Rest of World).

Quantity

2,762 units

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.

Lot, serial or model codes

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.

510(k) numbers

["K050954","K091641","K132952","K153594","K161367"]

PMA numbers

not on file

Product code

HCG

Firm FEI

3003523199

Firm city

Aliso Viejo

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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