Official recall record

Bipolar Hugo RAS Systems

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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