The Recall Desk
HighFDA (Devices)·Z-1405-2020·Announced 2020-03-04

MicroVention HydroSoft Embolization Coils Recalled for Missing Implant Coils

MicroVention is recalling 847 HydroSoft embolization coils because the implant coil may be missing from the packaging. The devices were distributed to 43 countries outside the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a critical component (the implant coil) may be missing. This presents a significant risk of harm if the device is used, but no injuries or illnesses have been reported in the source text, meeting the criteria for a High severity score.

Plain-English summary

MicroVention, Inc. is recalling 847 units of the MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, and HydroSoft 3D Endovascular Embolization Coils. The recall is being conducted because the devices may be missing the implant coil. The affected products are sterile, prescription-only medical devices intended for vascular occlusion of blood vessels within the neurovascular system and for arterial and venous embolizations in the peripheral vasculature.

The affected units were distributed to 43 countries outside the United States, including Albania, Austria, Belgium, Brazil, China, France, Germany, Italy, Japan, and the United Kingdom. The recall covers specific catalog and lot numbers, including 100102HFRM-V, 100152HFRM-V, and various MV-series reference numbers.

Healthcare providers and distributors in the affected countries should check their inventory for the specific catalog and lot numbers listed in the official recall notice. If the implant coil is missing from the packaging, the devices should not be used. MicroVention, Inc. is the recalling firm and is responsible for managing the recall.

The recalled product

Product
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202
Manufacturer
Microvention, Inc.
Category
Medical Device — Endovascular Embolization Coil
Hazard
Affected units
847

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: 100102HFRM-V - 1903045W6 and 1903135W6
  • 100152HFRM-V - 1903085W6
  • 1903185P6
  • and 1903185W6
  • 100153HFRM-V - 1903135W6
  • 100154HFRM-V - 1903015W6
  • 1903205W6
  • 1903225W6
  • 1904225P6
  • and 1904225W6
  • 100202HFRM-V - 1903065W6
  • 1903085W6
  • and 1903135W6
  • 100206HFRM-V - 1903065W6 and 1903085W6
  • 100208HFRM-V - 1903065W6
  • 100254HFRM-V - 1903045W6
  • and 1903115W6
  • 100256HFRM-V - 1903045W6 and 1903225W6
  • 100308HFRM-V - 1903115W6
  • 1903155W6

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.

See all 16 products in this recall →

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Same hazard · missing component

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