| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00133-1 |
| Product Name/Description |
Capio Suture Capturing Devices (SLIM, Standard, Open Access, RP)
For use with:
- Uphold Vaginal Support System (ARTG:150342) - Discontinued
- Uphold LITE with Capi SLIM Vaginal Support System (ARTG:150342) - Discontinued
- Pinnacle Anterior Pelvic Floor Repair Kit (ARTG:150342) - Discontinued
- Pinnacle Posterior Pelvic Floor Repair Kit (ARTG:150342) - Discontinued
- Pinnacle LITE Posterior with Capio SLIM Pelvic Floor Repair Kit (ARTG: 246992) - Discontinued
ARTG Number: 137473 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific (BSC) have observed a gradual increasing trend in reports regarding Capio suture breakage and/or detachment of the Capio suture darts from both the Capio suture and the pelvic floor kit mesh assembly. The mesh assembly refers to the portion of the pelvic floor delivery system which is removed from the patient following implantation of the mesh. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Boston Scientific are advising customers to refer to the updated Directions for Use provided in the Customer Letter.
This action has been closed out on the 16/11/2018. |
| Contact Information |
1800 676 133 - Customer Service Support |