Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Firing Failures
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 devices due to an increased trend of stapler firing failures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk surgical device where a functional failure (firing failure) poses a risk of harm to patients, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci EndoWrist Stapler 45, model number 470298, and associated reloads and accessories. These devices are intended for use with the da Vinci Xi Surgical System (Model IS4000) for resection, transection, and anastomosis creation in general, thoracic, gynecologic, and urologic surgery.
The recall was initiated because of an increase in customer complaints reporting a 'Stapler Firing Failed' message. A review of da Vinci Xi Surgical System logs confirmed an increased trend of these failures.
A total of 2,065 units are affected. The devices were distributed in the United States, including Puerto Rico, as well as in Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela. Healthcare facilities should stop using the affected devices and contact Intuitive Surgical for instructions.
The recalled product
- Product
- STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: 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
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 2,065
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
Distribution
Distributed in 1 state:
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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