Intuitive Surgical is recalling 110,580 Ion Vision Probe Bags used with the Ion Endoluminal System for lung biopsies. The recall was initiated because the sterile pouch seals on these probe bags may be compromised or incomplete. This robotic-assisted surgical accessory is a single-use item, and the potential for a faulty seal means the device inside may not be sterile during use. Consumers should contact their healthcare provider or the manufacturer for further guidance.
A compromised or incomplete seal on the sterile pouch can allow contaminants into the bag, increasing the risk of infection for patients during minimally invasive peripheral lung biopsy procedures.
Quantity: 110580. FDA Medical Device Listing Number: D414014. These are single-use sterile accessories for the Ion Endoluminal System robotic platform.
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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