| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01508-1 |
| Product Name/Description |
Uphold LITE with Capio SLIM and Solyx Single Incision Sling System
Catalogue Numbers: M0068318170 and M0068507000
ARTG Numbers: 150342 and 104326 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
On Tuesday, November 28, 2017, the Therapeutics Goods Administration (TGA) notified Boston Scientific of TGA’s decision to remove two transvaginally implanted Boston Scientific mesh products from the Australian Register of Therapeutic Goods (ARTG), effective January 4, 2018.
The TGA believes there is currently a lack of adequate scientific evidence for it to be satisfied that the risks to patients are outweighed by the benefits of these devices.
Further information can be found on the TGA website.
As a result Boston Scientific is recalling all Uphold LITE with Capio SLIM and Solyx Single Incision Sling System products from the Australian market.
No other Boston Scientific devices are affected by this recall. |
| Recall Action |
Recall |
| Recall Action Instructions |
Boston Scientific is advising hospitals to immediately discontinue use of and segregate affected product. The devices should be stored in a secure location for return to Boston Scientific. Instructions for product return are provided on the Customer Letter issued to affected customers.
This action has been closed out on the 22/11/2018. |
| Contact Information |
1800 676 133 - Boston Scientific |