Auto Suture Blunt Tip and Structural Balloon Trocar — recall 75231
Health Canada — Medical Devices · Canada · 2024-03-13 · Type II
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Gastroenterology and urology - General and plastic surgery
Product type
Medical devices
Reported risk: 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
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