Since 2008 the FDA has issued five pages of recalls against the company. The FDA defines Class 2 recall as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." The latest recall involves regarding friction with certain instrument arms, comes on the heels of growing controversy about robotic surgery involving the company's da Vinci system. Last year I did the documentary The Da Vinci Debate on CNBC.com.
Intuitive calls the latest recall "a product correction."
From its statement: "The company is taking this action after becoming aware that excessive friction within certain instrument arms could interrupt smooth instrument motion, which is felt as resistance by the surgeon. If a surgeon pushes through the resistance, the instrument could stall momentarily and then suddenly catch-up to the correct position."
The bigger issue, especially in the wake of falling sales at ISRG, is whether the da Vinci sales decline is the result of any hit to reputation from this and other "corrective" actions.
Current quarter's results will shed more light on that.
-- Written by Herb Greenberg
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