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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01227-1
Product Name/Description GastriSail Gastric Positioning System

Item Code: GPS36

All Lot Numbers

Expiry date: September 2017 to May 2018

ARTG Number: 246455
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 27/09/2017
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic is recalling specific production lots of its GastriSail Gastric Positioning System device.

This recall is being conducted following customer reports of oesophageal or gastric perforations during bariatric procedures where the GastriSai Gastric Positioning System was used. Eighteen reports, representing 0.08% of devices, were received regarding this issue; many of these perforations were identified post-operatively. According to complaints, the part of the device causing perforation may be the distal tip during device insertion or when meeting resistance as it is advanced. Some complaints also referenced tissue trauma or perforation thought to be caused by inability to fully retract the sail, leading to kinking of the sail and risk to tissue.
Recall Action Recall
Recall Action Instructions Medtronic requests that users quarantine and return any unused products of the items. All unused products from the affected item code and lots should be returned to Medtronic.

This action has been closed out on 31/10/2018
Contact Information 02 9429 4325 - Medtronic Australasia