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Health Canada Medical devices

Auto Suture Blunt Tip and Structural Balloon Trocar

Issued March 13, 2024
Issue
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
Hazard description
Performance
Product
Product name
Auto Suture Blunt Tip and Structural Balloon Trocar
Reference
ID
RA-75231