The Recall Desk
HighFDA (Devices)·Z-1395-2020·Announced 2020-03-04

MicroVention Platinum Coil System Recalled for Missing Implant Coil

MicroVention, Inc. is recalling 780 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.

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 missing component could lead to treatment failure or injury, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

MicroVention, Inc. is recalling 780 units of the MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft. The recall was initiated 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 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 recall covers specific catalog and lot numbers, including 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, and 100410HCSR-S-V. The source text does not specify the exact number of units affected by the defect, only the total quantity of 780 units involved in the recall.

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. Healthcare providers and facilities in these regions should verify their inventory against the provided lot numbers and contact MicroVention, Inc. for further instructions.

The recalled product

Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, 100410HCSR-S-V, Product
Manufacturer
Microvention, Inc.
Category
Medical Device — Endovascular Embolization Coil
Hazard
Affected units
780

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: 100206HCSR-S-V - 1903225UH
  • 1904055UH
  • 1904085UH
  • 1905085UH
  • 1905105UH
  • 1905105ZH
  • 1905135UH
  • 1905225UH
  • 1903015WL
  • 1903205WL
  • 1904295WL
  • 1905035WL
  • and 1905175PL
  • 100208HC-S-V - 1904035RL
  • 1904155LL
  • 1905035LL
  • 1905065LL
  • and 1905065VL 100208HCSR-S-V - 1905085UH
  • 1905155UH
  • 1903085RL

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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