Safety Scandal Overshadows Record Sales at Intuitive Surgical

Shares hit 52-week low after FDA's most severe recall for da Vinci staplers linked to serious injuries and death, overshadowing a 23% revenue beat and raised guidance.

The surgical robotics leader is living two lives. On one side, a blockbuster quarter that crushed expectations. On the other, a Class I FDA recall linked to life-threatening bleeding — and shares plunging to their worst levels of the year.

Intuitive Surgical stock tumbled nearly 7% on Monday to hit €355.50, a fresh 52-week trough. That marks a decline of roughly 26% since January. The slide was triggered by the U.S. regulator's most severe recall classification for certain da Vinci stapling instruments after reports of serious vascular injuries and at least one death. The recall category indicates a reasonable probability that the device could cause serious harm or death.

The sell-off underscores a widening gap between operational strength and market sentiment. For the first quarter, the company reported revenue of $2.77 billion — up 23% year-on-year and well ahead of the $2.62 billion analysts had pencilled in. Earnings per share hit $2.50, comfortably beating consensus estimates as well. The installed base of surgical robots expanded 12% to more than 11,300 units globally.

Procedure volumes continue to climb at double-digit rates, prompting management to lift its full-year growth forecast to as high as 16%. The new da Vinci 5 system is driving much of that demand. The tariff impact is expected to be negligible, shaving just 1% off projected revenue.

Yet safety concerns are now competing with the growth narrative for investors' attention. The recall specifically targets components used in the da Vinci system's stapling function. The company has not disclosed the exact number of affected units, but the FDA's Class I designation — its most serious — signals that the problem is not minor.

Competitive pressure is also mounting. Medtronic is pushing its Hugo robotic surgery system into the market, threatening to erode Intuitive Surgical's long-standing dominance. Some large institutional holders have trimmed their positions in recent weeks, amplifying selling pressure.

The company is navigating a leadership transition as well. At the annual meeting on April 30, shareholders confirmed Dave Rosa as the new chief executive, succeeding Gary Guthart, who moves to executive chair. The new management team will oversee the global rollout of da Vinci 5.

Despite the recent bloodletting, several major banks remain bullish. Barclays rates the stock at "Overweight" with a $651 price target. Goldman Sachs has a "Buy" rating and a $621 target. JPMorgan is also "Overweight" but trimmed its target to $550. At current levels, the forward price-to-earnings ratio has compressed to roughly 44, well below its five-year historical average.

The stock is trading more than 16% below its 200-day moving average — a technical measure that often signals extended weakness. For now, the market is prioritizing risk over reward, even as the underlying business delivers its best numbers in years.