| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00133-1 |
| Product Name/Description |
Covidien Auto Suture Structural Balloon Trocar & Auto Suture Blunt Tip Trocar
Covidien Auto Suture Structural Balloon Trocar
Product Number: OMS-T10SB
Covidien Auto Suture Blunt Tip Trocar
Product Code/Catalog Number: OMS-T10BTNL, OMS-T12BTNL, OMS-T10BT, OMS-T12BT
Lot Numbers: P3A0238, P2J0025 and P2J0083
ARTG 178500
(Medtronic Australasia Pty Ltd - Balloon dissector, surgical) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic have 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 during mesh insertion in the trocar. The user would not be able to detect these issues prior to use.
As of 20 February 2024, Medtronic has received 344 reports from customers globally related to this problem. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers must:
- Inform all surgeons and clinicians who handle the preparation and/ or placement of a Mesh Device that utilise the balloon and blunt tip trocar devices.
- Prior to using any Mesh device in conjunction with the following Trocars: Covidien Auto Suture Structural Balloon Trocar and Auto Suture Blunt Tip Trocar, carefully review and adhere to the mesh manufacturer’s Instructions for Use (IFU) on proper insertion techniques.
Medtronic is currently working on incorporating additional warning statement as revisions to the IFU aiming for the end of August 2024. |
| Contact Information |
0402897421 - Brett Mclachlan |