Intuitive Surgical recalls da Vinci Xi/X Tip-Up Fenestrated Graspers with potential for stainless steel fragments to fall into patients during surgery.
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
Intuitive Surgical is recalling da Vinci Xi/X Tip-Up Fenestrated Graspers that could break, causing stainless steel fragments to fall into patients during surgery. This poses a risk of injury if fragments are not detected.
The grasper has a manufacturing issue that can cause breakage in both upper and lower grips. If broken, stainless steel fragments may fall into the patient's body during surgery. These fragments could be detected or undetected, potentially causing injury.
Surgical teams using the da Vinci Xi/X Tip-Up Fenestrated Graspers with reference number 470347, version 12. Surgeons and surgical staff are most at risk during procedures.
Check for the product name 'da Vinci Xi/X Tip-Up Fenestrated Grasper', reference number 470347, and version 12. All lots are affected.
Verify the reference number 470347 and version 12 on the grasper.
The recall states the grasper has a potential for breakage that could cause stainless steel fragments to fall into patients during surgery, so it is not safe to use without recalling.
Check for the product name 'da Vinci Xi/X Tip-Up Fenestrated Grasper', reference number 470347, and version 12. All lots are affected.
The recall does not specify a remedy, so contact Intuitive Surgical directly 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-2059-2023 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2059-2023 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.
