MicroVention HydroFrame 10 Embolic Coils Recalled for Missing Implant Coil
MicroVention is recalling 991 HydroFrame 10 and HydroCoil embolic systems because the implant coil may be missing. The devices were distributed outside the United States.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. The hazard involves a missing critical component (implant coil) in a device intended for vascular occlusion, which poses a significant risk of treatment failure or injury, meeting the criteria for a Severe rating.
Plain-English summary
MicroVention, Inc. is recalling 991 units of the MicroVention Terumo HydroFrame 10 and HydroCoil Embolic Systems. These endovascular embolization coils are sterile, prescription-only devices intended for vascular occlusion in the neurovascular system and peripheral vasculature. The recall is being conducted because the devices may be missing the implant coil.
The affected products were distributed outside the United States to 41 countries, including Albania, Austria, Belgium, Brazil, China, France, Germany, Japan, and the United Kingdom. Specific reference numbers and catalog/lot numbers are listed in the official recall record.
Healthcare providers and distributors should stop using the affected devices and contact MicroVention, Inc. for further instructions. Consumers are not directly affected as these are prescription medical devices used by trained professionals.
The recalled product
- Product
- MicroVention 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, 100623HF
- Manufacturer
- Microvention, Inc.
- Affected units
- 991
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 16 recalled by Microvention, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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