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Auto suture blunt tip and structural balloon trocar
Official notice
13 Mar 2024
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
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
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.
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Affected products
Product 1
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Affected area 1
Company & contacts
Company & contacts
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Phone
Brand: Covidien, Auto Suture Blunt Tip And Structural Balloon Trocar.
Source & status
Source & status
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Tier
Category
Classification
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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