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An official Health Canada notice concerns Bipolar hugo ras systems. Medtronic is initiating a voluntary medical device field safety notice for specific serial numbers of the bipolar wristed instruments for the Hugo Robotic-Assisted Surgery (RAS) system. The instruments in scope have been identified to have an increased likelihood of component failure within the instrument's drive cable pulley assembly due to manufacturing variations. When this failure occurs, the instrument jaw's actuation and articulation will be incorrect, uncontrolled motion may occur, and a visible small white plastic portion of the instrument's pulley component may become disengaged and loose within the patient's cavity. The Hugo RAS system will detect this failure and halt telerobotic control of the affected instrument. Published 2026-02-19.
What to do now
Contact the manufacturer if you require additional information.
Recall number
81626
Official notice
2026-02-19
The hazard
The hazard
Medtronic is initiating a voluntary medical device field safety notice for specific serial numbers of the bipolar wristed instruments for the Hugo Robotic-Assisted Surgery (RAS) system. The instruments in scope have been identified to have an increased likelihood of component failure within the instrument's drive cable pulley assembly due to manufacturing variations. When this failure occurs, the instrument jaw's actuation and articulation will be incorrect, uncontrolled motion may occur, and a visible small white plastic portion of the instrument's pulley component may become disengaged and loose within the patient's cavity. The Hugo RAS system will detect this failure and halt telerobotic control of the affected instrument.
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How to check if you're affected
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Brand: Covidien.
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