Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-1397-2020 · Posted None

Recalling FirmMicrovention, Inc.
Recall StatusTerminated
Product CodeHCG
Date Initiated2019-11-22
Date Terminated2022-01-26
Product Quantity169 units

Reason for Recall

The devices may be missing the implant coil.

Firm Action

The recalling firm issued letters beginning 11/22/2019 dated 11/26/2019 via email using different flags according to the region the foreign consignee was located, i.e. 'URGENT: FIELD SAFETY CORRECTION ACTION" (for EMEA), "URGENT: MEDICAL DEVICE RECALL" (for Japan), or "FIELD SAFETY ADVISORY NOTICE" (for Rest of World).

Root Cause

Process design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc. · 2016-01-22K132952MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)MicroVention, Inc. · 2013-12-19K131948MICROPLEX COIL SYSTEM (MCS)MicroVention, Inc. · 2013-10-04K091641HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)MicroVention, Inc. · 2009-06-30K050954MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)MicroVention, Inc. · 2005-06-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑