This is a class one recall now as of last week. Notices were sent out to stop using the product immediately and to contact Ethicon. One product, the Proximate HCS hemorrhoidal circular stapler has been discontinued. The products were distributed during 2011 and 2012. The problem was with “firing’ which may result in a non complete staple. These products are used for colorectal surgeries and not where one wants to have a failure as the problem could also cause the damage to the rectal wall with splitting and bleeding or clogging the canal, ouch. BD
Johnson & Johnson (JNJ) has recalled more than 157,000 surgical stapler devices and accessories used in hemorrhoids treatment procedures due to potential malfunctions that pose a serious safety risk.
J&J's Ethicon Endo-Surgery division also has stopped selling one of the products in the U.S. "as part of a business decision," the company said in a statement.
The U.S. Food and Drug Administration said use of the recalled devices could cause serious adverse health consequences, including death. The agency assigned its most serious classification, Class 1, to the recall last week.
According to the FDA, the J&J products were recalled "due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.
"Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal," according to the FDA website. It can also cause splitting of rectal wall staple line and bleeding.