Intuitive Surgical recalls daVinci XI Sureform 60 Reload staples that may not deploy staples properly, risking air leaks during surgery. Affected units have specific lot numbers and are used in certain surgical procedures.
The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.
Intuitive Surgical is recalling certain daVinci XI Sureform 60 Reload surgical staples that may not deploy individual staples correctly. This could lead to incomplete staple lines, potentially causing air leaks or requiring additional surgery.
The staples may not deploy individual adjacent staples correctly, creating an incomplete staple line. This could lead to air leaks or anastomotic leaks, requiring additional surgical procedures to fix.
Surgical teams using the daVinci XI Sureform 60 Reload staples for procedures like general, thoracic, gynecologic, urologic, or pediatric surgery. Surgeons and surgical staff are most at risk if the staples fail to deploy properly.
Check for the product name 'daVinci XI Sureform 60 Reload', 60 mm black 6-Row 4.6 mm, Ref: 48360T-08, and UDI: 00886874113851. Affected units have specific lot numbers: T10180615, T10180924, T10181003, T10181010, T10181016, T10181029, T10181107, T10181109, T10181113.
Verify the product name, model, and lot numbers listed in the recall notice to confirm if your staples are affected.
The firm became aware of a manufacturing variation where black and green reloads may not deploy individual adjacent staples, potentially causing incomplete staple lines.
Failure to deploy staples correctly could lead to an air leak or anastomotic leak, requiring additional surgical procedures to fix.
Yes, affected units have lot numbers: T10180615, T10180924, T10181003, T10181010, T10181016, T10181029, T10181107, T10181109, T10181113.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1891-2020 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1891-2020 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.
