FDA Flags Safety Concern Over Intuitive Surgical Stapler

The U.S. Food and Drug Administration (FDA) on Wednesday issued an early alert highlighting a potentially high-risk issue with stapling devices manufactured by Intuitive Surgical, Inc. (NASDAQ:ISRG). Affected Stapler Devices Pulled From Use The FDA said Intuitive Surgical notified customers to remove specific curved-tip staplers from use or distribution. The affected products include the 8mm SureForm 30 Gray Reload, tied to designated parts and identification numbers. Customers have been directed to identify and stop using the impacted devices immediately. The company has also advised quarantining the products and ensuring any distributed units are located and returned. Device Widely Used Across Surgical Specialties The affected stapling system is commonly used with the da Vinci Surgical System across multiple disciplines, including general, thoracic, gynecologic, urologic, and pediatric surgeries. The devices are designed for tissue resection, vascular transection, and creation of surgical connections. Company Advises Switching To Alternatives In its communication dated March 11, 2026, Intuitive Surgical urged healthcare providers to transition to alternative surgical tools while the issue is being assessed. The FDA noted it is continuing to monitor developments and will update the public as new information emerges regarding the safety concern. Incomplete Staple Formation Raises Safety Risks The alert stems from reported cases where the stapler failed to form complete staple lines during procedures involving blood vessels. This malfunction may result in unintended tissue cutting and exposure of vessel contents, potentially leading to significant bleeding. Such complications may require surgeons to shift from minimally invasive procedures to open surgical techniques, increasing patient risk and recovery time. Injuries And Death Reported As of February 23, 2026, Intuitive Surgical has recorded four serious injuries and one death linked to the issue. ISRG Price Action: Intuitive Surgical shares were up 0.18% at $478.57 at the time of publication on Thursday, according to Benzinga Pro data. Image via Shutterstock