FDA Issues Class I Recall of Surgical Staplers
Healthcare professionals are being notified by the U.S. Food and Drug Administration (FDA) of a Class I medical product recall of certain Ethicon circular stapler sets as they pose a risk of causing severe injuries or death.
A Class I recall is issued by the FDA when a drug or medical device poses a threat of death or serious injury to patients.
Johnson & Johnson’s Ethicon Endo-Surgery unit recalled more than 157,000 of the surgical stapler devices and accessories used in the surgical treatment of prolapse and hemorrhoids, according to MarketWatch.
The staplers were recalled due to the difficulty of firing the device, which may result in an incomplete firing stroke of the stapler and incomplete staple formation. The problem can cause severe pain, rectal wall damage, bleeding, sphincter dysfunction, sepsis, and occlusion of the rectal canal, reports the FDA.
The inability of these staplers to complete the firing stroke can also lead to poor staple formation causing separation of the rectal wall staple line along with bleeding.
The devices under recall are the Proximate PPH hemorrhoidal circular stapler and accessories, the Proximate HCS hemorrhoidal circular stapler and accessories, and the Transtar circular stapler procedure set, according to the FDA. The lots affected by the recall were manufactured and distributed from April 2011 to July 2012.