Auto Suture Blunt Tip and Structural Balloon Trocar
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Auto Suture Blunt Tip Trocar |
More than 10 numbers, contact manufacturer. |
OMS-T10BTS |
Auto Suture Structural Balloon Trocar |
More than 10 numbers, contact manufacturer. |
OMS-T10SB |
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
Additional information
Details
Covidien Llc
15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
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