CLASS II Device recall · Reported 4 Mar 2020 · FDA Enforcement Report

Terumo Microplex 18, Platinum Coil System recalled by Microvention

Microvention is recalling MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, distributed in Georgia. The recall was initiated on 22 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog/lot numbers: 180204HC-S-V - 1903185WE and 1905105WE; 180208HC-S-V - 1904175PE, 1904175WE, 1904225WE, 1904265WE, 1904295WE, 1905025WE, 1905065PE, 1905065WE, 1905085WE, 1905175WE, 1905225WE; 180308HC-S-V - 1904225WE, 1904265WE, 1905025WE, and 1905035WE; 180410HC-S-V - 1903185WE, 1904015PE, 1904265WE, 1904295WE, 1905085WE, and 1905175WE; and 180512HC-S-V - 1903185WE, 1904265WE, 1904295WE, 1905085PE, 1905085WE, 1905155PE, 1905155WE, and 1905225WE.

Quantity recalled169 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1397-2020
FDA event ID: 84727
Recalling firm: Microvention, Aliso Viejo, CA
Classification: Class II
Status: Terminated
Recall initiated: 22 Nov 2019
FDA classified: 27 Feb 2020
Reported: 4 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

22 Nov 2019	Recall initiated by company
27 Feb 2020	Classified by FDA	+97 days
4 Mar 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The devices may be missing the implant coil.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Where it was distributed

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.

Georgia

Questions about this recall

Is Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 recalled?

Yes. Microvention recalled Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 on 22 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-1397-2020.

Why was it recalled?

The devices may be missing the implant coil.

Which lots are affected?

Catalog/lot numbers: 180204HC-S-V - 1903185WE and 1905105WE; 180208HC-S-V - 1904175PE, 1904175WE, 1904225WE, 1904265WE, 1904295WE, 1905025WE, 1905065PE, 1905065WE, 1905085WE, 1905175WE, 1905225WE; 180308HC-S-V - 1904225WE, 1904265WE, 1905025WE, and 1905035WE; 180410HC-S-V - 1903185WE, 1904015PE, 1904265WE, 1904295WE, 1905085WE, and 1905175WE; and 180512HC-S-V - 1903185WE, 1904265WE, 1904295WE, 1905085PE, 1905085WE, 1905155PE, 1905155WE, and 1905225WE.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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