| 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 |
|
| 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 |