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.
데이터 추가 비고
Catheter, percutaneous - Product Code DQY
원인
Reflow medical is recalling the wingman 35 crossing catheter because it may be prone to tip detachment.
조치
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.