Events

Recall of Device Recall Wingman 35 Crossing Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ReFlow Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76821
  • Event Risk Class
    Class 1
  • Event Number
    Z-1898-2017
  • Event Initiated Date
    2017-03-22
  • Event Date Posted
    2017-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154310
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, percutaneous - Product Code DQY
  • Reason
    Reflow medical is recalling the wingman 35 crossing catheter because it may be prone to tip detachment.
  • Action
    An Urgent Medical Device Recall letter was issued 3/22/17 for the Wingman 35 Crossing Catheter. The recall was issued due to a risk of catheter tip detachment which could cause injury to vasculature and thromboembolic events. Customers are asked to complete the Response Form and reply via email (quality@reflowmedical.com) or fax number (760.290.3216), even if they have no product to return. On 4/20/17, an Urgent Medical Device recall letter was sent to expand the recall to include all Wingman 35 Crossing Catheter lengths and lots manufactured since March, 2015. On 5/3/17, ReFlow Medical issue a press release to a news wire through PR.com to inform their customers that FDA is classifying this as a Class 1 recall. The press states that the Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. ReFlow has received 2 complaints of catheter-tip splitting and/or separation. A total of 2327 Wingman catheters are in distribution. Consumers with questions may contact ReFlow Medical Customer Relations at 1-949-481-0399, Monday through Friday, between 8:00 a.m. and 4:30 p.m. Pacific time or by email at info@reflowmedical.com. On 5/9/17, ReFlow Medical sent an updated press release to the newswire to correct the distribution dates from January 2015 and March 2016 to March 2015 and March 2017.

Device

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
    Cardiovascular Devices
  • 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
    ReFlow Medical

Manufacturer

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