Intuitive Surgical recalls da Vinci SP Instrument Arm Drape (REF 430013-12) due to potential tear during use, risking sterile barrier breaches. Affected units include all lots of this pouch.
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Intuitive Surgical is recalling the da Vinci SP Instrument Arm Drape pouch (model 430013-12) because it may tear while draping the Patient Side Cart, potentially breaking the sterile barrier. This could lead to infections during surgery if not properly maintained.
The drape may tear during the draping process for the Patient Side Cart, which breaks the sterile barrier. This could allow bacteria to enter the surgical site, increasing infection risk for patients.
Surgical teams using the da Vinci SP system are most at risk. Patients undergoing surgery with this drape could face infection risks if the sterile barrier is compromised.
Check for the model number 430013-12 on the pouch. This drape is sold with the da Vinci SP surgical system and is available in all lots.
Inspect the drape for tears or damage before use. If torn, stop using it immediately.
Reach out to Intuitive Surgical for guidance on handling the drape if you have concerns about sterility.
Yes, this drape is used during da Vinci SP surgical procedures to maintain sterility.
Look for the model number 430013-12 on the pouch. This drape is sold with the da Vinci SP system and is available in all lots.
If the drape tears, stop using it immediately to prevent a breach in the sterile barrier.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1906-2020 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1906-2020 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.
