Johnson & Johnson's ($JNJ) Ethicon unit is recalling lots of its Proximate hemorrhoidal staplers, and the FDA has assigned its most serious designation to the devices.
Ethicon launched the recall in August, warning that its Proximate PPH and Proximate HCS staplers can be too difficult for users to fire, possibly resulting in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding and occlusion of the rectal canal. Today, the FDA labeled the recall a Class I, warning that the devices could lead to serious injury or death.
The devices are used in the surgical treatment of prolapse or hemorrhoids, and in any procedure requiring anorectal tissue stapling. The affected lots were manufactured between April 2011 and July 2012, and Ethicon says it has notified affected customers of the recall. The FDA is asking patients and physicians to report adverse events through its online MedWatch system.
Ethicon has been no stranger to safety concerns over the past few years, recalling lots of its wound-sealing and wound-draining products last year and enduring hundreds of lawsuits over its fleet of vaginal mesh products, which were linked to severe adverse events in patients and marketed without the FDA's consent.
- read the FDA notice