The Recall Desk
HighFDA (Devices)·Z-1403-2020·Announced 2020-03-04

MicroVention HydroFrame 18 Embolic System Recalled for Missing Implant Coil

MicroVention is recalling 32 units of HydroFrame 18 embolic systems because the implant coil may be missing. The devices were distributed internationally.

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 is classified as FDA Class II. The hazard involves a missing critical component in a medical device used for vascular occlusion, which poses a risk of harm if the device fails to function as intended, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

MicroVention, Inc. is recalling 32 units of the MicroVention Terumo HydroFrame 18, HydroCoil Embolic System. The recall is due to a defect where the devices may be missing the implant coil. The affected reference numbers are 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA.

The recalled devices are intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation, as well as for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

All distribution of the affected product was outside the United States (OUS). The countries receiving the affected product include Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finland, 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.

The recalled product

Product
MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. Product Usage: The HES is also intended for vascular occlu
Manufacturer
Microvention, Inc.
Category
Medical Device — Endovascular Embolization Coil
Hazard
Affected units
32

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 (12)

  • Catalog/lot numbers: 180723HFRM-V - 1904175P7 and 1904175W7
  • 180931HFRM-V - 1904225P7 and 1904225W7
  • 181644HFRM-V - 1905025W7 and 1905155W7
  • MV-80619HHFA - 1904175X7
  • 1904175Y7
  • 1905065X7
  • and 1905085Y7
  • MV-80827HHFA - 1904175X7
  • 1904225Y7
  • and 1905065X7
  • MV-80931HHFA - 1905065X7
  • and MV-81036HHFA - 1904175Y7.

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 →

Related recalls

Same manufacturer · Microvention, Inc.

See all →

Same hazard · missing component

See all →