Intuitive Surgical recalls Da Vinci Single-Site Wristed Needle Driver REF 478115 (5mm) due to potential dislodgement or breakage causing uncontrolled movement. Affected units have specific serial numbers.
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
Intuitive Surgical is recalling a specific model of Da Vinci surgical needle driver because it can become dislodged or broken, leading to uncontrolled movement during surgery. This poses a risk to patient safety and requires immediate attention from users.
The needle drive can become dislodged or broken during use, causing uncontrolled movement. This could lead to unintended tissue damage or complications during surgical procedures.
Surgical teams using the Da Vinci Single-Site Wristed Needle Driver REF 478115 (5mm) are affected. Surgeons and surgical staff who have the specific serial numbers listed are most at risk.
Check for the specific serial numbers listed in the recall notice: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109.
Compare your device's serial number to the list provided in the recall notice.
The Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm.
It could cause uncontrolled movement during surgery, potentially leading to unintended tissue damage.
Check if your device has one of the specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0406-2024 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0406-2024 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.
