Intuitive Surgical Recalls da Vinci Xi Stapler Reloads Due to Missing Component
Intuitive Surgical is recalling da Vinci Xi Stapler 45 Reloads because a missing knife mechanism component may prevent the device from cutting tissue during surgery.
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 3/5 (High).
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 medical device where a functional defect (failure to cut tissue) poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Intuitive Surgical, Inc. (ISI) is recalling the da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03. The recall involves 6,816 units distributed to U.S., foreign, and government accounts. The affected devices have a UDI of 00886874112823 and expiration dates ranging from 10/14/2017 to 02/21/2020.
The recall was initiated because ISI became aware that some reloads may be missing a component of the knife mechanism. Without this specific component, the reload knife will not move or cut tissue when the stapler is fired. This defect affects the functional integrity of the surgical instrument during use.
Healthcare providers and facilities should stop using the affected da Vinci Xi Stapler 45 Reloads immediately. Users should contact Intuitive Surgical, Inc. for instructions on how to return or replace the devices. The recall covers units distributed in the United States and numerous foreign countries, including Australia, Canada, China, France, Germany, Japan, and the United Kingdom.
The recalled product
- Product
- da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 6,816
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)
- UDI: 00886874112823. Device expiration: 10/14/2017 02/21/2020
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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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