Intuitive Surgical recalls ION Reprocessing Accessories Kit IF1000 (Part 490024-03) due to potential catheter retention during cleaning, which may cause system failure. Affected units include specific reprocessing covers.
One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.
Intuitive Surgical is recalling ION Reprocessing Accessories Kits that include a specific reprocessing cover. This cover can become disengaged or incorrectly engaged, potentially trapping cleaning chemicals or water inside the catheter and causing system failure.
The reprocessing cover may become disengaged or incorrectly attached to the catheter during cleaning. This can trap cleaning chemicals or water inside the catheter, leading to system failure or potential damage to the surgical equipment.
Surgical staff using the ION system with the recalled reprocessing covers are most at risk. The recall affects all units sold with the specific cover part number.
Check for the ION Reprocessing Accessories Kit IF1000 (Part Number: 490024-03) with the reprocessing cover part number 490114-02. All units sold with this cover are affected.
Identify the reprocessing cover part number on the kit; it should be 490114-02 if affected.
Reach out to Intuitive Surgical for guidance on next steps if you have the affected cover.
The affected reprocessing cover has part number 490114-02.
Check if your ION Reprocessing Accessories Kit IF1000 has the reprocessing cover part number 490114-02.
The recall does not require immediate stop use; affected units should be checked and contacted 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-2950-2020 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2950-2020 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.
