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

FDA device recall Z-1898-2017 · posted 2017-03-29 · Terminated

Recall details

Recalling firm

ReFlow Medical

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

DQY

Quantity affected

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.

Date initiated

2017-03-22

Date posted

2017-03-29

Date terminated

2017-12-06

Location

San Clemente, CA

Related 510(k) clearances