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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the source text explicitly states the hazard is tool damage with no reported patient injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci Xi EndoWrist Stapler Release Kit (SRK), model number 470298, part number 381383-01. The device is intended for use with the da Vinci Xi Surgical System (Model IS4000) for resection, transection, and creation of anastomoses in general, thoracic, gynecologic, and urologic surgery.
The recall was initiated because Intuitive Surgical determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result in damage to the tool. The source text does not report any patient injuries, illnesses, or deaths associated with this issue.
A total of 2,059 units were shipped. Distribution was 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. Users should contact Intuitive Surgical for further instructions regarding the recall.
The recalled product
- Product
- STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Dutch 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: 381383-01
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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Same hazard · tool damage
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FDA (Devices) · 2017-04-12
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