| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00395-1 |
| Product Name/Description |
Covidien Endo GI Articulating Loading Units
Multiple Item and Lot Numbers
ARTG Number: 181429
(Medtronic Australasia - Surgical staple, non-bioabsorbable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified the potential for a device to be missing the sled component. The sled component is responsible for staple deployment. Without the sled, no staples would be deployed. Use of a product with this issue may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Internationally, Medtronic have received three reports of injury related to this issue. To date, there have been no reported injuries in Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is advising customers to immediately discontinue use of the affected products. Unused product should be quarantined and returned to Medtronic by following the instructions outlined on the Customer Letter. Medtronic will arrange collection of stock from customers and issue a credit for returned goods.
This action has been closed out on the 22/11/2018. |
| Contact Information |
02 9857 9000 - Medtronic |