Intuitive Surgical recalls Ion Catheter Reprocessing Cover model IF1000 (Part 490114-02) due to potential cleaning chemical retention during reprocessing, which may cause system failure.
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 a specific type of catheter reprocessing cover because it can become disengaged or incorrectly engaged, leading to cleaning chemicals or water staying in the catheter during reprocessing. This could cause the catheter or the entire surgical system to fail.
The cover may become disengaged or incorrectly engaged with the catheter during reprocessing. This can trap cleaning chemicals or water inside the catheter, potentially causing the catheter or the entire surgical system to fail.
Surgical staff and hospitals using the specific catheter reprocessing cover model IF1000 (Part Number 490114-02) are affected. The risk is highest for those using the cover during surgical procedures.
Check for the model IF1000 with part number 490114-02 on the cover. All lots of this specific cover are affected.
Inspect the cover for signs of disengagement or incorrect engagement with the catheter.
No, only the specific model IF1000 with part number 490114-02 is affected.
The recall record does not specify a remedy, so check the cover's condition and contact Intuitive Surgical for further guidance.
The recall states it may cause failure of the catheter or system, but does not mention injury risk.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2949-2020 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2949-2020 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.
