Intuitive Surgical recalls da Vinci Xi EndoWrist Stapler 45 Reload Blue (Model 48645B-03) due to potential missing knife component causing failure to cut tissue.
Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler 45 Reload Blue (Model 48645B-03) because the reload knife may not move or cut tissue when the stapler is fired due to a missing component. This could lead to improper tissue cutting during surgical procedures.
The reload knife may not move or cut tissue when the stapler is fired because a critical component is missing. This could result in the surgeon being unable to properly cut tissue during surgery, potentially leading to incomplete procedures or complications.
Surgical teams using the da Vinci Xi EndoWrist Stapler 45 Reload Blue (Model 48645B-03) are most at risk. Patients undergoing surgery with this specific reload may experience incomplete tissue cutting.
Check for the da Vinci Xi EndoWrist Stapler 45 Reload Blue (Model 48645B-03) with 12 reloads per box. The device expiration date is listed as 10/14/2017 or 02/21/2020 on the packaging.
Look for the device expiration date on the packaging, which is listed as 10/14/2017 or 02/21/2020.
Intuitive Surgical has become aware that the da Vinci Xi Stapler 45 Blue and Green Reloads may be missing a component of the knife mechanism, causing the reload knife to not move or cut tissue when the stapler is fired.
The recall record does not specify a remedy, so no action is required at this time.
The product may not function properly due to a missing component, so it should not be used until the issue is resolved.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2380-2018 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2380-2018 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.
