Medtronic Recalls Bipolar Hugo RAS System Instruments Due to Component Failure Risk

Source: Health Canada · Canada

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Medtronic has issued a voluntary field safety notice for specific Hugo RAS system instruments after identifying a manufacturing defect that could cause parts to break off inside patients.

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on February 20, 2026 and geographically references Canada. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Product & Food Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly Health Canada detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized Health Canada recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Medtronic (Covidien Llc) is initiating a voluntary medical device field safety notice for specific serial numbers of bipolar wristed instruments used with the Hugo Robotic-Assisted Surgery (RAS) system. The company identified an increased likelihood of component failure within the instrument's drive cable pulley assembly due to manufacturing variations. When a failure occurs, the instrument jaw's actuation and articulation become incorrect, potentially leading to uncontrolled motion. Additionally, a small white plastic portion of the pulley component may disengage and become loose within the patient's cavity.

Which Products Are Affected

The recall affects specific serial numbers for the following models:

  • Hugo RAS Bipolar Maryland Forceps: Model/Catalogue Number MRASI0005
  • Hugo RAS Bipolar Fenestrated Grasper: Model/Catalogue Number MRASI0004

There are more than 10 affected serial numbers. Facilities are advised to contact the manufacturer to verify if their specific units are included in this notice.

What You Should Do

The Hugo RAS system is designed to detect this specific failure and will automatically halt telerobotic control of the affected instrument if the issue is identified. Healthcare providers and facilities using these instruments should contact the manufacturer, Covidien Llc (Medtronic), for further instructions and to confirm affected serial numbers. The company is located at 15 Hampshire Street, Mansfield, Massachusetts, 02048.

Why This Matters

This recall is critical because component failure during robotic surgery can lead to uncontrolled instrument movement and the introduction of foreign plastic debris into a patient's body cavity, posing serious safety risks during surgical procedures.

Source

Health Canada

Original source: Health Canada Official Notice ↗

All Product & Food Recalls →

Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Medtronic has issued a voluntary field safety notice for specific Hugo RAS system instruments after identifying a manufacturing defect that could cause parts to break off inside patients.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.