Intuitive Surgical recalls da Vinci Xi Sureform 45 and Curved-Tip models due to tissue pushout events causing bleeding risks during surgery. Affected units include specific model numbers and serial codes.
As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitive s existing risk documentation.
Intuitive Surgical is recalling certain da Vinci Xi Sureform 45 surgical robots because they can push tissue distally instead of cutting it, leading to bleeding risks. This could cause serious bleeding during surgery if the device is used improperly.
The Sureform stapler can push tissue distally (away from the surgeon) instead of holding it in place for cutting. This causes bleeding in critical areas during surgery, which can lead to serious complications if not addressed.
Surgical teams using the da Vinci Xi Sureform 45 or Curved-Tip models are most at risk. Patients undergoing surgery with these devices may face bleeding complications.
Check for model numbers: Sureform 45 (REF 480445), Sureform 45 Curved-Tip (REF 480545), or Sureform 60 (REF 480460). All units with these model numbers and serial codes are affected.
Identify the model number on your device: Sureform 45 (REF 480445), Sureform 45 Curved-Tip (REF 480545), or Sureform 60 (REF 480460).
The device can push tissue distally instead of cutting it, causing bleeding risks during surgery. This has been identified through complaint data review.
Check your model number to see if it's affected. If it is, contact Intuitive Surgical for guidance on next steps.
The recall record does not mention a specific remedy or fix. Affected users should contact Intuitive Surgical for further instructions.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0999-2022 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0999-2022 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.
