ReFlow Medical: Medical Device Recall in 2017 - (Recall #: Z-1898-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE

Product Classification:

Class I

Date Initiated: March 22, 2017

Date Posted: May 24, 2017

Recall Number: Z-1898-2017

Event ID: 76821

Reason for Recall:

ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.

Status: Terminated

Product Quantity: 2,794 units

Code Information:

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.

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of : NJ, FL, CA, GA, MI, OH and countries of: Germany, Turkey, and AU.

Voluntary or Mandated:

Voluntary: Firm initiated