FDA Medical Device Recalls (openFDA)
ReFlow Medical: Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
- Recall number
- Z-1898-2017
- Recalling firm
- ReFlow Medical
- Product
- Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
- Status
- Terminated
- Initiated
- 2017-03-22
- Posted
- 2017-03-29
- Terminated
- 2017-12-06
- Reason
- ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.
- Root cause
- Under Investigation by firm
- 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.
- Quantity
- 2,794 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of : NJ, FL, CA, GA, MI, OH and countries of: Germany, Turkey, and AU.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K141547"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 3008789872
- Firm city
- San Clemente
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28