Z-1392-2020Class II

MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile...

Name: Z-1392-2020 MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile...
Creator: Microvention, Inc.
Published: 2019-11-22
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2019-11-22 / Terminated / root cause: manufacturing process

FDA source

Microvention, Inc. began a recall of MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V... on 2019-11-22. FDA classified it as Class II and gives the reason as "The devices may be missing the implant coil". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1392-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-22
Posted: 2020-02-27
Terminated: 2022-01-26
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: HCG Device, Neurovascular Embolization
Reason for recall: The devices may be missing the implant coil.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1392-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1392-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1393-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1394-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1395-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1396-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1397-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1398-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1399-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1400-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1401-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1402-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1403-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1404-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1405-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1406-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27
Z-1407-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-27

Product code HCG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)