Recall Z-1898-2017 ยท DQY Catheter, Percutaneous
ReFlow Medical
Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
| Date | Mar 29, 2017 (initiated Mar 22, 2017) |
| Status | Terminated |
| 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 iss |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141547 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER Reflow Medical, Sep 30, 2014 |