Device Recall Wingman 35 Crossing Catheter

  • Model / Serial
    Lot Numbers   Model number: WGM35065US 1508074, 1509154R, 1510204, 1510054R, 1602164,1604194R,1605133,  1606273R2, 1701244.  Model number: WGM35090US 1502053, 1505144,1508264R, 1508265,1601044,1603024,1603214, 1605193, 1606304, 1610314.  Model number: WGM35135US 1503094, 1505061, 1506104, 1508204R, 1508205, 1510074R, 1511304, 1512174,1512174R, 1602174, 1604213, 1604253, 1605113, 1606203, 1611034.  Model No. WGM35065CE 1508074R, 150874R1, 1509154, 1510024, 1510024R, 1510054, 1602164R, 1604194, 1606273, 1606273R.  Model No. WGM35090CE 1502053R, 1505144R, 1505144R1, 1505144R2, 1505144R3, 1508264, 1601044R, 1603024R, 1603024R2, 1603214R, 1603214R2, 1605194, 1605194R, 1605194R2.  Model No. WGM35135CE 1503094R, 1503094R1, 1503094R2, 1505061R, 1505264, 1506104R, 1508204, 1508205R, 1510074, 1602174R, 1604213R, 1606203R, 1606203R2, 1606204, 1606204R, 1611114.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of : NJ, FL, CA, GA, MI, OH and countries of: Germany, Turkey, and AU.
  • Product Description
    Wingman 35 Crossing Catheter, 65cm, || Model Numbers: || WGM35065US || WGM35065CE || WGM35090US || WGM35090CE || WGM35135US || WGM35135CE
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    ReFlow Medical, 1003 Calle Sombra, San Clemente CA 92673-6244
  • Manufacturer Parent Company (2017)
  • Source
    USFDA