Z-1392-2020 Class II Terminated
FDA device recall Z-1392-2020 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: 2,762 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
- 2,762 units
Product Description
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.
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: 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.