FDA Medical Device Recalls (openFDA)
Microvention, Inc.: 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.
- Recall number
- Z-1397-2020
- Recalling firm
- Microvention, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2019-11-22
- Posted
- not on file
- Terminated
- 2022-01-26
- Reason
- The devices may be missing the implant coil.
- Root cause
- Process design
- 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).
- Quantity
- 169 units
- 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, serial or model codes
- 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.
- 510(k) numbers
- ["K050954","K091641","K131948","K132952","K153594"]
- PMA numbers
- not on file
- Product code
- HCG
- Firm FEI
- 3003523199
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28