Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk
Intuitive Surgical is recalling da Vinci Xi Surgical System cannula seals because particulates could enter the cannula lumen during surgery.
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 medical device where particulates could be introduced into a patient's body during surgery. While the source text does not report specific injuries or illnesses, the potential for harm in a surgical context aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci Xi Surgical System cannula seals (part number 470380, model numbers 470380-04, 470380-05, and 470380-06). The recall involves 46,191 boxes of the product, which are distributed worldwide across numerous countries including the United States, Australia, and various European and Asian nations.
The recall is being issued due to a potential for particulates in the insufflation stopcocks on the cannula seals. According to the source text, these particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure. The seals are used to maintain insufflation when the cannula is empty and when instruments are inserted.
This recall affects all lots of the affected model numbers. The source text does not specify specific dates of distribution or identify specific hospitals or facilities affected, but notes the global distribution pattern. Healthcare facilities should contact Intuitive Surgical for instructions on how to handle the recalled product.
The recalled product
- Product
- SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the s
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 46,191
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 lots
Distribution
Distributed in 1 state:
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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