MASSDEVICE ON CALL — Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery’s global surgical stapler recall got Class I status from the FDA over concerns that issues with the devices’ firing mechanisms may injure patients.
MassDevice.com in August reported on the recall, which involves certain lots of Ethicon’s Proximate PPH and HCS hemorrhoidal circular staplers and accessories, when the company notified authorities in Hong Kong of the recall.
J&J launched the recall over issues firing the device, which could result in incomplete staple formation, according to the Hong Kong letter.
"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 notice. "Failure to complete the firing stroke can also result in poor staple formation, dehiscence of the rectal wall staple line and bleeding."
The recall affects more than 157,000 surgical stapling systems distributed worldwide, the Wall Street Journal reported.
South Dakota courts device makers
South Dakota government representatives are heading to Minnesota for the medical Design & Manufacturing Exposition in Minneapolis, hoping to lure device makers back to their home state.
New tech for cheaper home care
New technologies aim to provide lower-cost home care, including a wireless medical and home safety monitoring system with medication management and treatment plan compliance.
Fresenius prepares for the storm
Dialysis-provider Fresenius (NYSE:FMS) activated its emergency response team to ensure that its service centers in the U.S. Northeast and Mid-Atlantic regions can stay up and running as Hurricane Sandy prepares to roll through.
Healthcare as a job-growth driver
Missouri Governor Phil Bryant (R) wants to leverage the healthcare industry to drive job growth, including luring more doctors to the state, especially in rural areas.
On June 4-5, DeviceTalks Minnesota is taking over the Twin Cities medtech industry with one of the most anticipated conferences of the spring.
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