Covidien recalls electrode kits after 4 serious burn injuries
Covidien announces the 2nd recall in as many months after at least 4 patients were burned by grounding pads contained in some tumor ablation kits.
The medical device maker recalled the pads and the Cool-tip RFA ablation systems that contain them after at least 4 patient experienced "serious injuries, burns at the pad site," according to the company.
The Cool-tip RFA system is an ablation device that may be used as an alternative to surgery for some cancers in the liver or other soft tissue, according to Covidien's website. The device in May 2006 won FDA clearance for use in non-resectable liver tumors.