Intuitive Surgical recalls 8MM MEGA SUTURECUT ND IS4000 devices with frayed or broken grip cables that could cause injury during use. Affected units include specific model numbers and batch dates.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical is recalling 8MM, MEGA SUTURECUT ND, and IS4000 devices that have frayed or broken grip cables. This hazard could lead to injury if the device slips during surgery.
Frayed or broken grip cables on reusable surgical instruments could cause the device to slip during use. This might lead to injury to the patient or the surgical team if the instrument moves unexpectedly.
Surgical staff and hospitals using the affected models are most at risk. Patients undergoing surgery with these devices could be impacted if the grip cable fails.
Check for model number 470309 with part number 470309-15 or 470309-17. Batch numbers K10230217 and K10230302 are also associated with this recall.
Look for model number 470309 with part numbers 470309-15 or 470309-17.
Reach out to Intuitive Surgical for guidance on next steps if you have the affected model.
Frayed or broken grip cables on reusable surgical instruments could cause the device to slip during use, potentially leading to injury.
Check for model number 470309 with part numbers 470309-15 or 470309-17 and batch numbers K10230217 or K10230302.
Contact Intuitive Surgical for guidance on next steps, as the recall does not specify a replacement or repair process.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0865-2025 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0865-2025 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.
