| TGA Action ID |
RC-2026-RN-00658-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Shiley Hi-Lo Evac Cuffed Tracheostomy Tubes supplied with a Hi-Lo cuff, standard 15 mm connector, obturator (where applicable), and tape tie.
Tube Sizes: 6.0 mm, 7.0 mm, 8.0 mm, 9.0 mm, 10.0 mm
Product Numbers: 313-60, 313-70, 313-80, 313-90, 313-10
All lots. |
| ARTG Number |
181271 |
| Unique Device Identifier (UDI) |
10884522043229, 10884522043199, 10884522043205, 10884522043212, 10884522043250 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
The problem involves unintended separation at the 15 mm connector interface while the tracheostomy cannula remains properly positioned in the patient's airway and secured with a tracheostomy fixation device. Although the airway remains patent, separation at the connector may interrupt the connection between the tracheostomy tube and respiratory support equipment, including ventilators and breathing circuits. Serious injury or death could occur if this problem is not promptly recognised and managed. While no reports of death have been received, Medtronic has received reports of serious injury potentially associated with this problem.
In mechanically ventilated or ventilator-dependent patients, unintended separation at the 15mm connector interface may result in loss of ventilatory support, which can lead to respiratory compromise if not promptly recognised and corrected. In patients who are breathing spontaneously, the immediate clinical impact may be more limited; however, the unintended separation remains clinically significant requiring prompt recognition and intervention to maintain intended airway management and therapy. Reported harms include respiratory failure and delays or interruptions in treatment. Additional potential harms may include aspiration/inhalation and unspecified tissue injury. |
| Instructions for Customers/Users |
Customers are to quarantine all unused product from all lots of Shiley Hi-Lo Evac Tracheostomy Tube Cuffed. Stock should be returned to Medtronic per the instructions in the Customer Letter. |
| Action Commencement Date |
28/08/2026 |
| Responsible Entity |
|
| Contact Information |
(02) 9857 9000 - John Paul Ribeiro |