medical MODERATE Updated 2020-03-04

Microvention, Inc. recalls MicroVention Terumo Microplex 10, Platinum Coil System, Endo

See all recalls from Microvention, Inc. →

Recalled Product

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.

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Hazard / Issue

The devices may be missing the implant coil.

Issued by

FDA

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: 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.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

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