Intuitive Surgical recalls da Vinci S/Si Mega Needle Driver instruments with potential broken or frayed grip cables. These reusable surgical tools may cause injury if cables fail during use.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Intuitive Surgical is recalling da Vinci S and Si Mega Needle Driver instruments due to reports of broken or frayed grip cables. This could lead to instrument failure during surgery, potentially causing injury to patients or the surgical team.
The grip cables in these instruments can become broken or frayed, which may cause the instrument to malfunction during surgery. If the cable fails while in use, it could lead to unintended movement or injury to the surgical site.
Surgical teams using da Vinci S or Si systems with Mega Needle Driver instruments. Patients undergoing surgery with these instruments are at risk if the cables fail during procedures.
Check for the model number 420194 on the instrument or packaging. These instruments were sold with specific batch/system numbers listed in the recall notice, including lot codes like 420194-08 through 420194-13.
Look for the model number 420194 on the instrument or its packaging. This includes specific batch/system numbers listed in the recall notice.
Contact Intuitive Surgical directly to confirm if your instrument is affected and to get instructions for replacement or repair.
Intuitive Surgical is recalling these instruments due to increased complaints about broken or frayed grip cables, which could cause instrument failure during surgery.
Check for the model number 420194 on the instrument or packaging. Affected instruments have specific batch/system numbers listed in the recall notice, including lot codes like 420194-08 through 420194-13.
No, but you should check if your instrument is affected and contact Intuitive Surgical for instructions. The recall does not require immediate discontinuation of use.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1698-2026 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1698-2026 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.
