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Auto suture blunt tip and structural balloon trocar

Official notice

13 Mar 2024

Last checked

13 Mar 2024

Medium riskHealth Canada
Watch Covidien

An official Health Canada notice concerns Auto suture blunt tip and structural balloon trocar. Medtronic received reports of events related to Covidien Auto Suture™ Structural Balloon Trocar and Auto Suture™ Blunt Tip Trocar reporting trocar seal disengagement when using the trocar with certain mesh products. This issue can occur when the trocar is used to deploy the mesh not in accordance with the mesh instructions for use (IFU). Not following the IFU for the mesh including use of incompatible trocar size, excess force, and not hydrating the mesh and/or folding of the mesh could result in a seal disengaging into the cavity. Recall Start Date: March 4, 2024 Published 2024-03-13.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75231

Official notice

2024-03-13

The hazard

Medtronic received reports of events related to Covidien Auto Suture™ Structural Balloon Trocar and Auto Suture™ Blunt Tip Trocar reporting trocar seal disengagement when using the trocar with certain mesh products. This issue can occur when the trocar is used to deploy the mesh not in accordance with the mesh instructions for use (IFU). Not following the IFU for the mesh including use of incompatible trocar size, excess force, and not hydrating the mesh and/or folding of the mesh could result in a seal disengaging into the cavity. Recall Start Date: March 4, 2024

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

75231

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Affected products

Product 1

Affected products - Auto Suture Structural Balloon Trocar, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - OMS-T10SB

Risk / hazard

Medtronic received reports of events related to Covidien Auto Suture™ Structural Balloon Trocar and Auto Suture™ Blunt Tip Trocar reporting trocar seal disengagement when using the trocar with certain mesh products. This issue can occur when the trocar is used to deploy the mesh not in accordance with the mesh instructions for use (IFU). Not following the IFU for the mesh including use of incompatible trocar size, excess force, and not hydrating the mesh and/or folding of the mesh could result in a seal disengaging into the cavity. Recall Start Date: March 4, 2024

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Covidien, Auto Suture Blunt Tip And Structural Balloon Trocar

Manufacturer

Not provided

Phone

Not provided

Brand: Covidien, Auto Suture Blunt Tip And Structural Balloon Trocar.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75231

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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