Wingman35 Catheter Recall Issued Over Tip Splitting, Separation Problems
More than 2,300 catheters distributed to hospitals nationwide are subject to a recall, following reports that suggest the devices may split or separate at the tip, causing a loss of function and serious medical risk that may prevent blood flow to organs.
A ReFlow Medical Wingman35 Crossing Catheters recall was announced by the FDA on May 3, after at least two reports have problems were received. While no serious injuries have occurred, defects may allow the catheter tip to split or separate during use, which may lead to severe health consequences or death.
The recalled catheters are designed to be inserted into the body cavity through a narrow opening for removing fluid. The occurrence of splitting or separation will result in loss of device function and require medical intervention to retrieve the separated segment.
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In the event the catheter tip breaks or splits, it could cause blood clotting and starve organs from blood flow, creating a life threatening event. Surgical intervention to remove the separated segment may be required.
The recall includes Wingman35 Crossing Catheters that were manufactured by ReFlow Medical of Clemente, California, where they were sold and distributed to medical and healthcare facilities across the United States from January 2015 through March 2016.
ReFlow Medical has already begun notifying its customers and distributors by recall notification letters requesting that all customers and distributors quarantine and immediately discontinue use of all recalled lots. If customers or distributors are unsure of the product is included in the recall, ReFlow is urging consumers to quarantine the products until further confirmation.
The FDA has categorized the recall as Class I, which is the most serious classification. It indicates that the problems leading to the recall have a reasonable probability of causing severe injury or death.
Customers are being asked to stop using the recalled products immediately and to contact ReFlow Medical Customer Relations team at 1-949-481-0399 or email them at email@example.com.
Customers who have experienced adverse health consequences or events from the use of the recalled Wingman35 catheters are encouraged to contact the FDA’s MedWatch Adverse Event Reporting program.
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