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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

Endo GIA 45mm Extra Thick Black Articulating Reload with Tri-Staple Technology
Item Code: EGIA45AXT
Lots: N8A0907KX and N8A0146KX

Endo GIA 60mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology
Item Code: EGIA60AVM
Lot: N8B0088KX
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 6/06/2018
Responsible Entity Medtronic Australasia Pty Ltd
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