In April 2014, a Class I recall of ConvaTec's Flexi-Seal CONTROL Fecal Management System Kit was announced. According to the FDA recall release, the company did not file for 510(k) clearance of the product. The device is intended to be used in patients with fecal incontinence.
The device is known to be defective because the balloon doesn't inflate or deflate completely, the auto-valve doesn't prevent inflation beyond 45 mL and leaks at the inflation port. FDA reports that these flaws may lead to rectal damage, leakage or expulsion of the device, and skin injuries due to fecal contact.
There were 12 serious injuries and one death reported in Flexi-Seal CONTROL patients between February 2013 through March 2014.
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