Intuitive Surgical recalls 8MM Large Needle Drivers with frayed grip cables that could cause injury during surgery. Affected models include IS4000 REF 470: 470006-12 and 470006-13 with specific batch numbers.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical is recalling 8MM Large Needle Drivers that have frayed or broken grip cables. This could lead to injury during surgical procedures if the cable fails while in use.
The grip cables on these instruments can fray or break during use, potentially causing the instrument to slip or malfunction. This could lead to injury to the patient or the surgical team if the cable fails while in operation.
Surgical staff using the recalled 8MM Large Needle Drivers for procedures. Those with the specific model numbers and batch dates listed are most at risk.
Check for model number 470006 with part numbers 470006-12 or 470006-13. Batch numbers include K10230120, K10230118, K12230119, K11230118, K10230217 for the first part, and K10230623, K10240506, K10240815 for the second part.
Inspect the grip cable for fraying or breaks before use. If found, stop using the instrument immediately.
Reach out to Intuitive Surgical for guidance on safe handling or replacement options.
The affected model numbers are 470006 with part numbers 470006-12 and 470006-13.
Batch numbers include K10230120, K10230118, K12230119, K11230118, K10230217 for part 470006-12, and K10230623, K10240506, K10240815 for part 470006-13.
Check the model number and batch numbers listed in the recall notice. The affected instruments have specific part numbers and batch dates.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0849-2025 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0849-2025 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.
