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.
- Company
- Microvention Inc.
- Recall Initiated
- November 22, 2019
- Terminated
- January 26, 2022
- Recall Number
- Z-1397-2020
- Quantity
- 169 units
- Firm Location
- Aliso Viejo, CA
Reason for Recall
The devices may be missing the implant coil.
Distribution
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.
Lot / Code Info
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.
Root Cause
Process design
Action Taken
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).