Intuitive Surgical recalls da Vinci Xi and X 12-8 mm Conductive Cannula Reducer (REF: 470381-11) due to risk of metal tip dislodging, potentially causing tissue damage or bowel obstruction if not removed during surgery.
Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.
Intuitive Surgical is recalling da Vinci Xi and X 12-8 mm Conductive Cannula Reducers because the metal tip might detach from the plastic shaft. If not noticed, extra surgery may be needed to remove the metal tip, which could lead to tissue damage, bowel obstruction, or chronic abdominal pain.
The metal tip can become dislodged from the plastic shaft during surgery. If not detected, it may require additional surgery to remove, which could cause tissue damage, bowel obstruction, or chronic abdominal pain if the tip remains inside the patient.
Surgical patients and medical professionals using the da Vinci Xi and X 12-8 mm Conductive Cannula Reducer during procedures. Those at highest risk are patients who may have the metal tip left behind after surgery.
Check for the da Vinci Xi or X 12-8 mm Conductive Cannula Reducer with reference number 470381-11. The product has unique identifiers (UDI) listed in the recall notice.
Inspect the cannula reducer for any metal tip that has become detached from the plastic shaft.
Reach out to Intuitive Surgical directly for instructions on whether the cannula reducer needs to be removed or replaced.
The metal tip may dislodge from the plastic shaft during surgery, potentially requiring additional procedures to remove it and causing tissue damage, bowel obstruction, or chronic abdominal pain.
Check for a dislodged metal tip and contact Intuitive Surgical for specific guidance on whether to remove or replace the cannula reducer.
Yes, if the metal tip remains inside the patient after surgery, it could cause bowel obstruction and chronic abdominal pain.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0702-2022 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0702-2022 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.
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.
