STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

Class I - Dangerous

🏥 Medical Devices Recalled: July 14, 2016 Intuitive Surgical Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
All model 470298
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Intuitive Surgical, Inc.
Reason for Recall:: Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

Product Codes/Lot Numbers:

All model 470298

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2675-2016

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