Intuitive Surgical recalls daVinci XI Sureform 60 reloads with potential incomplete staple lines, risking air leaks or surgical complications during 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 specific daVinci XI Sureform 60 reload staples that may not deploy staples properly, which could cause air leaks or require additional surgery. This affects surgeons using these staples in certain procedures.
The recalled staples may not deploy individual adjacent staples correctly, leading to incomplete staple lines. This could cause air leaks or anastomotic leaks, requiring additional surgical interventions to fix.
Surgeons using the recalled daVinci XI Sureform 60 reloads for procedures like general, thoracic, gynecologic, urologic, or pediatric surgery. Those most at risk are medical professionals performing surgeries with these specific staples.
Check for the specific model: daVinci XI Sureform 60 reload, 60 mm Green 6-Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844. These were sold with lot numbers T10180511 through T11190219.
Verify the model number and lot numbers listed in the recall notice to confirm if your staples are affected.
The firm discovered a manufacturing variation where black and green reloads may not deploy staples properly, risking incomplete staple lines.
Incomplete staple lines could lead to air leaks or anastomotic leaks, requiring additional surgical procedures to fix.
Check for the model: daVinci XI Sureform 60 reload, 60 mm Green 6-Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, with lot numbers T10180511 through T11190219.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1890-2020 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1890-2020 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.
