Intuitive Surgical recalls Da Vinci Xi 8mm SureForm 30 Curved-Tip Staplers due to potential staple deployment failure and device fragment generation. Affected models include specific colors and serial numbers.
Potential staple deployment failure and device fragment generation
Intuitive Surgical is recalling Da Vinci Xi 8mm SureForm 30 Curved-Tip Staplers because they may fail to deploy staples properly, causing fragments to break off. This could lead to serious injury during medical procedures if the device malfunctions.
The stapler may fail to deploy staples correctly, causing metal fragments to break off during surgery. This could lead to serious injury if fragments damage tissues or organs during the procedure.
Surgical teams using the Da Vinci Xi 8mm SureForm 30 Curved-Tip Staplers for minimally invasive procedures are most at risk. Patients undergoing surgery with these devices may face complications if the stapler malfunctions.
Check for the model name 'Da Vinci Xi 8mm SureForm 30' with specific color codes: gray (48230M), white (48230W), or blue (48230B). The serial numbers listed in the recall include 10886874121723, 10886874121938, 10886874121921, and 10886874121914.
Look for the serial numbers listed in the recall: 10886874121723, 10886874121938, 10886874121921, or 10886874121914.
Reach out to Intuitive Surgical directly for further assistance or to confirm if your device is affected.
The affected models include Da Vinci Xi 8mm SureForm 30 Curved-Tip Staplers in gray (48230M), white (48230W), and blue (48230B) colors with specific serial numbers listed in the recall.
The recall does not specify a fix or remedy; affected users should contact Intuitive Surgical directly.
Check for the model name 'Da Vinci Xi 8mm SureForm 30' with the specific color codes and serial numbers listed in the recall.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0340-2023 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0340-2023 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.
