Intuitive Surgical recalls ION Fully Articulating Catheter model 490105-08 (VER 08) due to risk of distal tip ring dislodging during procedures. All units with serial numbers listed may be affected.
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Intuitive Surgical is recalling ION Fully Articulating Catheter model 490105-08 (version 08) because the distal tip ring might become dislodged during medical procedures. This could lead to complications if the catheter moves unexpectedly in the lung.
The distal tip ring of the catheter can become dislodged during medical procedures, potentially causing the catheter to move unexpectedly in the lung. This could lead to complications such as unintended tissue damage or procedural errors.
Healthcare professionals using the ION Fully Articulating Catheter for lung procedures are affected. Patients undergoing these procedures are at risk if the catheter dislodges during treatment.
Check for the model number 490105-08 (version 08) on the product label. Affected units have serial numbers listed in the recall notice, including many starting with S10181217 through S10200825.
Look for the model number 490105-08 (version 08) on the catheter label.
Confirm if your catheter has a serial number listed in the provided range (S10181217 to S10200825).
Yes, the ION Fully Articulating Catheter is used to navigate within the lung to a planned path for sampling targets.
The distal tip ring may become dislodged during procedures, potentially causing the catheter to move unexpectedly in the lung and leading to complications.
Check for the model number 490105-08 (version 08) and verify your serial number is in the list provided (S10181217 to S10200825).
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0489-2021 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0489-2021 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.
