Intuitive Surgical Recalls da Vinci Xi Stapler Release Kits
Intuitive Surgical is recalling da Vinci Xi Stapler Release Kits because misinterpretation of instructions may result in tool damage.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is limited to potential tool damage due to instruction misinterpretation, with no reported injuries, illnesses, or structural defects causing harm to patients.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci Xi EndoWrist Stapler Release Kit (SRK), model number 470298, part number 381389-01. The recall involves 2,059 units shipped in all languages.
The recall was initiated because Intuitive Surgical determined that misinterpretation of the instructions provided on the IS4000 Stapler Release Kit instruction card may result in damage to the tool. The device is intended for use with the da Vinci Xi Surgical System for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery.
The affected units were distributed worldwide, including the United States (nationwide) and internationally to Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Luxembourg, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela. Healthcare facilities and users should stop using the affected kits and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Italian SRK General and Plastic Surgery: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 2,059
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part number: 381389-01
Distribution
Part of a larger recall action
This product is one of 16 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
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