Covidien ($COV) launched a voluntary recall of its DGPHP RFA grounding pads and the Cool-tip RFA electrode kits that use them, marking the company's second recall this month.
The devicemaker warns of potential foil degradation in the single-use grounding pads, which warranted four reports of serious injury related to the problem, as patients suffered burns at the pad site. The grounding pads are designed to return the currents of active electrodes, and the Cool-tip devices ablate tumors in the liver of other soft tissues.
The recall affects DGPHP techs--including those contained in Cool-tip devices--manufactured before Aug. 30, 2011, and the company notified patients and physicians of the recall on Aug. 6. The FDA is aware of the recall and urges patients to submit adverse event accounts through its MedWatch online reporting platform. The agency has yet to assign a class to the recall.
The grounding pad recall is the second for Covidien in August, as it warned of leakage in its Shiley tracheostomy tubes earlier this month, launching a recall the FDA later labeled a Class I, its most serious designation.
- read the FDA's release
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