Public recall detail

Bipolar Hugo RAS Systems

2026-02-19

medium
General and plastic surgery Performance
Quick summary

Quick summary: Bipolar Hugo RAS Systems. Reason: Performance. Category: General and plastic surgery. Date: 2026-02-19.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Bipolar Hugo RAS Systems. Reason: Performance. Category: General and plastic surgery. Date: 2026-02-19.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandCOVIDIEN LLC
ProductBipolar Hugo RAS Systems
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81626

Affected products

ProductHugo RAS Bipolar Maryland Forceps
LotMore than 10 numbers, contact manufacturer.
ModelMRASI0005
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHugo RAS Bipolar Maryland Forceps
ProductHugo RAS Bipolar Fenestrated Grasper
LotMore than 10 numbers, contact manufacturer.
ModelMRASI0004
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHugo RAS Bipolar Fenestrated Grasper

Issue

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 you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesCovidien Llc 15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
Recall date2026-02-10
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81626
Background{}
CompaniesCovidien Llc 15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
AudiencesHealthcare
Source updated2026-02-19

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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