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Bipolar hugo ras systems

Official notice

19 Feb 2026

MediumHealth Canada

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

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

MRASI0005, MRASI0004

Other

RA RA-81626

Model Numbers

MRASI0005, MRASI0004

Recall Numbers

81626

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Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - MRASI0005

Product 2

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - MRASI0004

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Covidien.

Source & status

Source

Health Canada

Tier

beta

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

81626

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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