| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00655-1 |
| Product Name/Description |
Covidien Endo GIA Articulating Reloads with Tri-Staple Technology
Endo GIA 45mm Articulating Medium/Thick Reload with Tri-Staple Technology
Item Code: EGIA45AMT
Lot: N7L0521KX
ARTG:181429
Endo GIA 45mm Extra Thick Black Articulating Reload with Tri-Staple Technology
Item Code: EGIA45AXT
Lots: N8A0907KX and N8A0146KX
ARTG:181429
Endo GIA 60mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology
Item Code: EGIA60AVM
Lot: N8B0088KX
ARTG:186247 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified the potential for the device to have a misassembled (reversed) sled component. The sled component is responsible for staple deployment. When the device is applied to tissue and fired, a misassembled sled may result in the tissue being transected without the deployment of staples to seal the point of transection. This may result in bleeding, immediate anastomotic leak, and/or the potential for death if this is used on a critical vascular structure such as the pulmonary artery and renal artery.
Internationally, Medtronic have received one report 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 13/02/2019 |
| Contact Information |
02 9857 900 - Medtronic Australia |