Covidien is conducting a voluntary recall of certain production lots of the DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip™ RFA Electrode Kits that contain DGPHP RFA High-Power Single Use Grounding Pads.
The company has voluntarily decided to recall specific lots manufactured prior to August 30, 2011, due to the potential degradation of foil within the DGPHP grounding pad. Covidien has received reports of four serious injuries, burns at the pad site on the patient, which may be related to this product quality issue.
The affected product descriptions and lots are available on Covidien’s notification missive here.
Covidien says it is working with the United States Food and Drug Administration (FDA) and other regulatory authorities on this voluntary recall.