Covidien recalls electrode kits
Published date : 22 August 2012
Article date : 21 August 2012
Covidien has announced the 2nd recall in as many months of its tumor ablation kits. This follows the occurence of at least 4 patients being burned by grounding pads. The manufacturer has recalled the pads and the Cool-tip RFA ablation systems that contain them.
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. The device in won FDA clearance in May 2006 for use in non-resectable liver tumors.
The kit delivers radiofrequency energy which heats and destroys target tissue, either through open surgery, percutaneously or laparoscopically based on a physician's preference. The 4 single-use grounding pads go across the thighs and it is this component that has caused the issue. Covidien recalled certain lots of the pads and the kits manufactured prior to August 30, 2011, according to the recall notice.
In June the FDA asked Covidien to defend its management of the recall of its Duet TRS surgical staples which were removed from the shelves after they were implicated in 13 patients injuries and 3 deaths.
Source: Mass Device, 20 August 2012
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