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Boston Scientific's SCS leads linked to 1,081 serious injuries in FDA alert. Boston's recall comes at a time where several players in the medtech industry are facing personal injury lawsuits over SCS system malfunctions. The US Food and Drug Administration (FDA) has issued an alert over Boston Scientific's recall of a lead kit used with its spinal cord stimulator (SCS) system at a time when the company and other medtech industry players are facing lawsuits over SCS systems malfunctioning. In a letter sent to customers on 17 June, Boston said the body of its Infinion CX leads, which are compatible with its SCS systems for relieving chronic pain in the back and limbs, including Spectra WaveWriter and WaveWriter Alpha, may experience "mechanical stress at the anchor site", an issue that may result in high impedance measurements or lead fractures. These abnormal impedance measurements may lead to inadequate stimulation and/or additional intervention, including lead explant and replacement, the company stated as per the FDA alert. SCS is a form of neuromodulation used for treating chronic, severe nerve pain in the trunk, arms, or legs when conservative treatments have failed. As of 27 May, Boston Scientific has reported 1,081 serious injuries and no deaths associated with this issue. While the action does not affect SCS devices that have already been implanted, Boston now recommends that all unused Infinion CX leads be removed from where they are used or sold. Boston's recall comes at a time in which the company, alongside other players in the medtech industry with SCS systems, including Medtronic and Abbott, are facing lawsuits regarding device failure, shocks, and lack of pain relief. A series of lawsuits pertaining to Boston's SCS systems were formally centralised into a single federal multidistrict litigation (MDL) on 5 June 2026 for coordinated proceedings. Meanwhile, in August 2026, Abbott opposed the creation of a proposed MDL seeking to consolidate 23 personal injury lawsuits involving its SCS systems into a single proceeding in the Central District of California. According to GlobalData analysis, the global neurology devices market, of which SCS systems are a part, is projected to reach a valuation above $25bn in 2034. Meanwhile, a recent report from GlobalData forecasts that the SCS market will be worth $3.5bn in North America in 2033. Give your business an edge with its leading industry insights.

Medtronic announces partnerships, investments with Cornerstone Robotics and Pi-Cardia. The medtech company will gain access to surgical robotics and structural heart technology through the agreements. Published September 04, 2026 Medtronic announced a strategic partnership with Cornerstone Robotics, an innovative surgical robotics company committed to advancing minimally invasive surgery and improving access to the latest surgical care worldwide. The approximately $700 million investment includes rights to distribute Cornerstone Robotics' Sentire surgical system in select markets outside the U.S. where the system is market approved. Medtronic will distribute Sentire alongside its Hugo robotic-assisted surgery (RAS) system. Together with Medtronic's connected surgical ecosystem, the two complementary platforms will expand access to robotic-assisted surgery and offer surgeons and health systems more choice and flexible solutions designed to meet their diverse needs and reach more patients globally. With global adoption of robotic-assisted surgery still in the single digits, the opportunity to expand access to advanced surgical care for patients, physicians, and health systems around the world is significant. Expanded choice and access are critical drivers of the future of robotic assisted surgery. Through this partnership, Medtronic and Cornerstone Robotics are building a multi-port portfolio anchored by the Hugo RAS system and expanded by Sentire, giving customers meaningful flexibility across clinical settings, procedural needs, and economic models. "Our strategy is focused on driving the next generation of minimally invasive surgery, one of our biggest growth opportunities," says Matt Anderson, senior vice president and president, Surgical, Medtronic. "Surgeons, health systems and markets have varying needs and preferences, which is why we are investing across robotic platforms, digital tools, and platform-enhancing technologies. With Sentire complementing the Hugo RAS system, Medtronic will be the only company offering this two-platform portfolio combined with our surgical ecosystem - giving customers more access, more choice, and flexible solutions that fit their clinical and operational needs." Building on Hugo's momentum. The partnership builds on the momentum of Medtronic's Hugo RAS system, which is now being used in more than 35 countries across six continents, including the United States, where it received FDA clearance within the last year. Procedure growth for the Hugo RAS system is currently more than 2x the growth rate of the robotic surgery market, and total procedures are expected to exceed 50,000 globally by the end of Medtronic's fiscal year. Medtronic will continue to innovate the capabilities of the Hugo RAS system, including ongoing software upgrades, real-time artificial intelligence across its digital ecosystem, integrated stapling, expanded instrumentation, and clinical indications. The modular, multi-quadrant platform is designed for a broad range of soft-tissue surgical procedures and combines wristed instruments, 3D visualization, and Touch Surgery ecosystem with dedicated support for robotics program optimization, service, and training. Expanding access through Sentire surgical system. The Sentire system's architecture and immersive console with dual-console capability offer a familiar configuration suited to varying surgeon preferences and clinical needs. Developed entirely in-house by Cornerstone Robotics, Sentire has completed multi-specialty clinical trials and received CE Mark in May 2026 for use in minimally invasive general, gynecologic, thoracic, and urologic surgical procedures in addition to its market approval in China and Singapore. "Since the founding of Cornerstone Robotics, we have been steadfast in our commitment to innovation, excellence, and clinical value," says Samuel Au, founder and CEO, Cornerstone Robotics. "We are confident physicians and patients alike will be the greatest beneficiaries of this partnership as we continue to expand access across this dynamic market." Medtronic continues to invest across its surgical ecosystem to expand access to robotic-assisted solutions for operating rooms around the world. This partnership is another step in strengthening that connected ecosystem and advancing the company's commitment to improving the lives of patients through minimally invasive surgery. Investment in Pi-Cardia. Medtronic also announced a strategic investment in Pi-Cardia Ltd., a pioneer in leaflet modification technologies for structural heart disease. With a focus on addressing the evolving needs of increasingly complex transcatheter aortic valve replacement (TAVR) patients and procedures, Medtronic secures an option for strengthening its structural heart portfolio through this strategic investment, supporting the next generation of innovation. Pi-Cardia's ShortCut device is the first FDA-cleared leaflet modification technology designed to enable valve-in-valve TAVR procedures in patients at risk of coronary obstruction. The device provides physicians with a safe, easy-to-learn, reproducible approach to leaflet modification that can help preserve coronary access and enable future transcatheter valve procedures. In FDA-reviewed clinical studies, ShortCut demonstrated successful leaflet splitting in all pivotal trial patients and a favorable safety profile. "As structural heart care evolves, we're investing in technologies that help physicians address today's challenges while preparing for tomorrow's opportunities," says Jorie Soskin, vice president and general manager of the Structural Heart business within Medtronic's Cardiovascular portfolio. "Our investment in Pi-Cardia reflects our commitment to building a portfolio of technologies that will shape the future of TAVR, particularly for patients with complex anatomy. We believe leaflet modification technologies like ShortCut have the potential to become an important component of structural heart care and the future of TAVR as transcatheter therapies continue to advance." Under the agreement, Medtronic will make strategic investments of up to $80 million into Pi-Cardia and is expected to become the exclusive global commercial distributor of the ShortCut device in 2027. Medtronic will leverage its worldwide Structural Heart organization to expand physician access across the United States, Europe, Japan, and other international markets. The agreement also includes an option for Medtronic to acquire Pi-Cardia upon achievement of predefined milestones for an estimated upfront acquisition price of up to $210 million, subject to customary adjustments, plus additional potential earn-out payments post-acquisition that could meaningfully increase the total consideration. The transactions are subject to regulatory approval and customary closing conditions. "Our mission has been to make leaflet modification a standard part of complex TAVR," says Erez Golan, chief executive officer of Pi-Cardia. "Medtronic is the right partner to help us achieve this vision given their global reach and commitment to bringing innovative tools to physicians and patients worldwide. We are confident this collaboration will accelerate adoption of ShortCut while continuing to advance the future of leaflet modification." The strategic investment secures an option for Medtronic to strengthen its structural heart portfolio by adding a first-of-its-kind technology that addresses a significant challenge in valve-in-valve TAVR while complementing the company's leadership in transcatheter valve therapies. It also reflects Medtronic's commitment to partnering and investing early in innovations that can improve patient outcomes, expand future treatment options, and support long-term growth. Pi-Cardia was founded by Erez Golan and Eyal Kolka, and is backed by experienced medtech investors including Sofinnova Partners, Sprig Equity, and Jacques Séguin, whose commitment has helped advance the company's vision of developing transformative leaflet modification technologies. Get curated news on YOUR industry. Enter your email to receive its newsletters.