Intuitive Surgical recalls da Vinci SP Instrument Arm Drape, SP, 1-PACK (Part Numbers 430013-13, 430013-15) due to potential detachment of drapes causing procedure delays. Affected units sold with specific lot numbers.
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes that may detach during surgery, potentially causing procedure delays or requiring a switch to a different surgical method. This recall affects specific model numbers and lot batches sold to hospitals and surgical centers.
The drape rings at the top of the product may detach during use, exposing part of the instrument arm. This could lead to surgery being delayed or requiring a different minimally invasive approach, but does not pose an immediate risk of injury to patients.
Hospitals and surgical centers using the da Vinci SP system with the recalled drape model numbers are most at risk. Patients undergoing surgery with these specific drapes may experience delays or alternative procedures.
Check for the product name 'da Vinci SP Instrument Arm Drape, SP, 1-PACK' with part numbers 430013-13 or 430013-15. Affected units have specific lot numbers listed in the recall notice.
Identify the part numbers and lot numbers listed in the recall notice to confirm if your drape is affected.
The drape rings may detach during surgery, potentially causing procedure delays or requiring a switch to a different surgical method.
Check for part numbers 430013-13 or 430013-15 with specific lot numbers listed in the recall notice.
No immediate action is required, but you should check the product details to confirm if your drape is affected.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2722-2026 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2722-2026 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.
