Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Field Failures
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 instruments due to reported field failures involving shaft rotation interruptions and jaw opening issues.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the source reports specific field failures (shaft rotation interruption, jaws not opening) in a surgical device, which aligns with the rubric criteria for Severe severity involving significant injury or property damage reports/structural defects.
Plain-English summary
Intuitive Surgical, Inc. is recalling 875 units of the da Vinci EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (Model 470298). These instruments are 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 after field failures were reported where 30 instruments experienced an interruption in shaft rotation and/or the instrument jaws did not open. The affected products were distributed worldwide, including nationwide in the United States and in Australia, Belgium, Denmark, France, Germany, Italy, Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey.
Healthcare facilities and users should stop using the affected instruments and contact Intuitive Surgical, Inc. for further instructions on the recall.
The recalled product
- Product
- 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…
- Manufacturer
- Intuitive Surgical, Inc.
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)
- All model 470298
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
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Similar recalls
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