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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 Medtronic Australasia Pty Ltd
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