Intuitive Surgical recalls da Vinci X/Xi vessel sealers with 8mm EndoWrist instruments (REF 480: 00886874115664) due to risk of insufficient seal when excessive tissue is placed in jaws.
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Intuitive Surgical is recalling certain da Vinci X and Xi surgical vessel sealers because placing too much tissue in the instrument jaws can cause an insufficient seal. This could lead to bleeding or other complications during surgery.
The seal can become too weak if too much tissue is placed between the instrument jaws before sealing. This may cause bleeding or tissue damage during surgery.
Surgical teams using the recalled da Vinci X or Xi vessel sealers with 8mm EndoWrist instruments. Surgeons and surgical staff are most at risk during procedures.
Check for the model name 'VESSEL SEALER EXTEND' with 8mm EndoWrist instruments on da Vinci X or Xi systems. The unique identifier (UDI) starts with 00886874115664.
Verify the instrument model is 'VESSEL SEALER EXTEND' with 8mm EndoWrist for da Vinci X or Xi systems.
Reach out to Intuitive Surgical for guidance on whether the instrument is affected.
No, only da Vinci X and Xi systems with the specific 8mm EndoWrist instruments.
The recall record states it could result in bleeding or tissue damage during surgery.
Check for the model name 'VESSEL SEALER EXTEND' with 8mm EndoWrist on da Vinci X or Xi systems and the UDI starting with 00886874115664.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1209-2022 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1209-2022 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.
