Intuitive Surgical, Inc. has recalled 3 units of the Ion Endoluminal System, specifically model REF: 380748-65. The recall was initiated because certain screws in the robotic system's instrument cart arm may fail, which can lead to the robotic catheter moving uncontrollably while inside a patient's airways. This defect affects three specific systems with serial numbers EN1230, EN1241, and EN1231. Because these are complex surgical systems used in hospital settings, the manufacturer has reached out to affected facilities via notification letters.
If the internal screws fail, the robotic arm may lose stability or precision, causing the catheter to move unexpectedly within the patient's lung or airway. This uncontrolled motion can cause internal physical trauma, tissue damage, or respiratory complications during medical procedures.
Manufacturer Notification and Device Inspection
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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