MicroVention Terumo Microplex 10 recall
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V…
Why was MicroVention Terumo Microplex 10 recalled?
The devices may be missing the implant coil.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V…
- Recalling firm
- Microvention, Inc.
- 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.
- Recall date
- March 4, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)