Microvention, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1394-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620HC-R-V, 100620HCSR-R-V, 100730HC-R-V, 100730HCSR-R-V, 100830HC-R-V, 100930HC-R-V, 100930HCSR-R-V, 101030HC-R-V, and 101030HCSR-R-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.

Product Classification:

Class II

Date Initiated: November 22, 2019

Date Posted: March 4, 2020

Recall Number: Z-1394-2020

Event ID: 84727

Reason for Recall:

The devices may be missing the implant coil.

Status: Terminated

Product Quantity: 486 units

Code Information:

Catalog/lot numbers: 100515HC-R-V - 1903135RL, 1905135RL, 1903115LL, 1903135LL, 1903155LL, 1903225LL, 1904015LL, 1904175LL, 1905025LL, 1905035LL, 1905065LL, and 1905085LL; 100515HCSR-R-V - 1903225UL, 1904245UL, 1903045WL, 1903115WL, 1904015PL, 1904225WL, 1905065WL, and 1905225WL; 100520HC-R-V - 1905175LL, 1905205LL, 1905205VL; 100520HCSR-R-V - 1904245UL, 1904295UL, and 1903085WL; 100620HC-R-V - 1903115LL, 1905035LL, and 1905065LL; 100620HCSR-R-V - 1904245UL; 100730HC-R-V - 1905155LL, 1905175LL, and 1905225LL; 100730HCSR-R-V - 1904175PL, 1904225WL, and 1905035WL; 100830HC-R-V - 1905135RL, 1905135LL, and 1905175LL; 100930HC-R-V - 1903115LL; 100930HCSR-R-V - 1903085ZL, 1903115UL, 1903135UL, and 1904245UL; 101030HC-R-V - 1903135RL; and 101030HCSR-R-V - 1904245UL and 1903015RL.

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.

Voluntary or Mandated:

Voluntary: Firm initiated