Intuitive Surgical recalls 8MM SutureCut Needle Driver model 470296 with frayed grip cables that could break during use, posing a risk of injury. Affected units include specific batch numbers.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical is recalling a specific model of suture driver due to frayed or broken grip cables. This could cause the instrument to break during use, potentially leading to injury.
The grip cables on these reusable surgical instruments can fray or break during use. If the cable breaks while the instrument is in operation, it could cause the instrument to malfunction or become unstable, potentially leading to injury.
Surgical professionals and hospitals that use this specific model of suture driver are most at risk. The recall affects instruments with the model number 470296 and specific batch numbers.
Check for the model number 470296 on the instrument. Affected units include batch numbers K10230217 through K16240613.
Inspect the grip cable for fraying or breaks. If present, stop using the instrument immediately.
Reach out to Intuitive Surgical for guidance on next steps or to confirm if your instrument is affected.
The product may have frayed or broken grip cables, which could cause injury during use. Do not use if you see frayed cables.
Affected batch numbers include K10230217, K10230302, K10230413, K10230420, K10230427, K10230824, K10231123, K10240229, K10240425, K10240627, K10240718, and K16240613.
The recall record does not specify a replacement process. Contact Intuitive Surgical directly for assistance.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0864-2025 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0864-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
