Intuitive Surgical recalls Ion Endoluminal System (REF: 380748-65) due to potential screw failure causing uncontrolled catheter movement in airways. Affected units have specific serial numbers.
There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
Intuitive Surgical is recalling its Ion Endoluminal System (REF: 380748-65) because screws in the instrument cart arm might fail, causing a catheter to move uncontrollably inside a patient's airways. This could lead to serious injury during medical procedures.
The system's instrument cart arm may contain screws that can fail, causing the catheter to move unpredictably inside a patient's airways. This could lead to serious injury during medical procedures if the catheter moves uncontrollably.
Medical professionals using the Ion Endoluminal System for procedures are most at risk. Patients undergoing surgery with this system could be affected if the device malfunctions.
Check for the product reference number 380748-65 on the system. Affected units have specific serial numbers: EN1230/10591271, EN1241/10591273, or EN1231/10583014.
Verify your system's serial numbers against the listed affected units: EN1230/10591271, EN1241/10591273, or EN1231/10583014.
The instrument cart arm may contain screws that can fail, causing the catheter to move uncontrollably inside a patient's airways.
Check for the product reference number 380748-65 and serial numbers: EN1230/10591271, EN1241/10591273, or EN1231/10583014.
The recall does not specify a remedy, so contact Intuitive Surgical directly for guidance.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2720-2024 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2720-2024 from Intuitive Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
