| TGA Action ID |
RC-2026-RN-00695-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
GORE CARDIOFORM Septal Occluder (GSO)
Catalogue Part Numbers: GSXE0020B, GSXE0025B, GSXE0030B
Expiry Dates: Between October 3, 2027 and August 23, 2028 |
| ARTG Number |
202817 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
W. L. Gore & Associates (Gore) has received 12 complaints regarding a missing guidewire port (monorail port) on the delivery system which is part of the GORE CARDIOFORM Septal Occluder (GSO) device.
This may lead to increased procedure time based on the inability to prepare or introduce the device.
If the device has already been implanted, no complications related to this problem are anticipated. |
| Instructions for Customers/Users |
Customers are to:
Inspect the product prior to use in the patient. Do not use if the product has been damaged.
- If the guidewire port is present, the device may be utilised as intended, no additional action is required.
- If the device is missing the guidewire port, do not use the device. Customers are to follow their local procedures for processing unused devices and report the observation to the manufacturer. |
| Action Commencement Date |
15/09/2026 |
| Responsible Entity |
|
| Contact Information |
02 9473 6800 - Gore Customer Service |