FDA Medical Device Recalls (openFDA)
Microvention, Inc.: 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 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. The firm name on the label is MicroVention, Inc., Tustin, CA.
- Recall number
- Z-1395-2020
- Recalling firm
- Microvention, Inc.
- 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 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. The firm name on the label is MicroVention, Inc., Tustin, CA.
- 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
- 780 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: 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, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1903085RL, 1903015WL, and 1903065WL; 100306HCSR-S-V - 1903085WL and 1904015PL; 100308HCSR-S-V - 1904105UH, 1904155UH, 1903015PL, 1903015WL, 1903045WL, 1903085WL, 1903185WL, 1905135WL, and 1905175PL; 100310HC-S-V - 1903045VL, 1904155LL, 1905035LL, 1905065LL, and 1905155LL; 100310HCSR-S-V - 1904245UL, 1904265UL, 1903015WL, 1903085WL, and 1903185WL; 100410HC-S-V - 1904155LL, 1904175LL, 1905035LL, 1905065LL, and 1905135RL; and 100410HCSR-S-V - 1904105UL, 1903015WL, 1903085WL, and 1903185WL.
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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