Intuitive Surgical recalls Da Vinci surgical systems with specific part numbers due to potential E-brake pin failure causing uncontrolled motion and patient injury.
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
Intuitive Surgical is recalling Da Vinci surgical systems with part number 380601 that may have a defective E-brake retainer pin. If the system's structural column fails, the pin could prevent the E-brake from engaging, leading to uncontrolled motion and potential patient injury.
The E-brake retainer pin in the recalled part may not engage properly during a structural column failure. This can cause the surgical system to move uncontrollably, potentially injuring patient tissue or causing crushing injuries and bleeding.
Surgical patients and medical professionals using Da Vinci surgical systems with the specific part number 380601. Those who have the system installed with the recalled part are at risk of uncontrolled motion during surgery.
Check if your Da Vinci surgical system has part number 380601. The serial numbers listed in the recall include many specific numbers starting with 605408, 606848, and others. The UDI (Unique Device Identifier) is 00886874114605.
Compare your Da Vinci surgical system's serial number against the list of affected serial numbers provided in the recall.
Reach out to Intuitive Surgical directly for assistance with the recall process.
The E-brake retainer pin in the surgical system's part number 380601.
Check if your system's serial number is listed in the provided list of affected serial numbers (e.g., 605408, 606848, etc.).
Contact Intuitive Surgical directly for instructions on the recall process.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2521-2026 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2521-2026 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.
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.
