Yesterday, the FDA issued a safety alert warning of ReFlow Medical’s 4/22/17 lot-specific voluntary recall of its Wingman35 Crossing Catheters distributed between January 2015 and March 2016. According to the FDA, the Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.
The FDA is classifying this as a Class 1 recall, the most serious recall situation where the patient is exposed to a reasonable likelihood of death or a serious injury.
How We Can Help:
If you or someone you love has suffered injury following a procedure with a catheter, you should be aware of this recall and the FDA safety announcement.
Attorney Pamela A. Borgess, the founder of Borgess Law, LLC, has successfully represented multiple clients who have sustained serious injury or whose loved ones have died as a result of defective or recalled medical drugs and devices. Attorney Borgess will happy to discuss your legal options. For more information about the recall or safety alert, or to discuss a potential claim, contact Borgess Law at (567) 455-5955 or toll-free at (844) LAW-9144. You can also contact Borgess Law by submitting an online inquiry. Borgess Law never charges for initial consultations. We welcome any questions you may have.