MicroVention Terumo HydroFrame 10 recall
MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V…
Why was MicroVention Terumo HydroFrame 10 recalled?
The devices may be missing the implant coil.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V…
- Recalling firm
- Microvention, Inc.
- Quantity
- 991 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.
- Recall date
- March 4, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)