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.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are categorized as Severe (Score 4), particularly given the functional failure of a surgical instrument during a procedure.
Plain-English summary
Intuitive Surgical, Inc. (ISI) is recalling the da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03. The recall involves 7,337 units of the device, which are distributed in boxes of 12 reloads.
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. The affected devices have a UDI of 00886874112878 and expiration dates ranging from 10/14/2017 to 02/21/2020.
The affected products were distributed to U.S., foreign, and government accounts. Foreign distribution includes Australia, Austria, Belgium, Brazil, Canada, China (Hong Kong), Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, and the United Kingdom. Users should stop using the affected reloads and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 7,337
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: 00886874112878. 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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