Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk
Intuitive Surgical is recalling da Vinci Xi cannula seals because particulates may enter the cannula lumen during surgery, potentially affecting patients.
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 medical device where a defect (particulate introduction) poses a risk of harm to patients 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. is recalling the da Vinci Xi Surgical System cannula sterile single-use disposable seals (Part number 470361; Model numbers 470361-03, 470361-04, 470361-05, 470361-06). The recall involves 46,191 boxes of seals, which were distributed worldwide to countries including the United States, Australia, and various European and Asian nations.
The recall is being conducted 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 designed to maintain insufflation when the cannula is empty and when instruments are inserted into the patient.
Healthcare facilities and consumers who possess these specific seals should stop using them and contact Intuitive Surgical, Inc. for further instructions on return or replacement. The recall covers all lots of the affected product.
The recalled product
- Product
- SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when th
- 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 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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