Intuitive Surgical recalls 8MM medium-large clip appliers with frayed or broken grip cables that could cause injury during surgery. Affected models include IS4000 with specific batch numbers.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical is recalling 8MM medium-large clip appliers 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 clip appliers can fray or break during use, especially when handling reusable surgical instruments. If the cable fails while the device is in operation, it could cause injury to the surgical team or patient.
Surgical professionals using the IS4000 clip appliers with specific batch numbers are most at risk. Patients undergoing surgery with these devices may face injury if the grip cable fails.
Check for the model number 470327 and batch numbers listed in the recall notice, such as K10221120 through K14240411. The device is labeled as '8MM, MEDIUM-LARGE CLIP APPLIER, IS4000'.
Look for the model number 470327 and batch numbers listed in the recall notice, such as K10221120 through K14240411.
Reach out to Intuitive Surgical directly for further assistance with the recall.
The model number is 470327 for the 8MM medium-large clip applier.
Affected batch numbers include K10221120 through K14240411 as listed in the recall notice.
The recall does not require immediate stop use; however, you should check if your device is affected and contact Intuitive Surgical 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-0867-2025 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0867-2025 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.
