| TGA Action ID |
RC-2025-RN-00692-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ViziShot 2 FLEX (19G)
Model: NA-U403SX-4019
Multiple Lot Numbers |
| ARTG Number |
346852 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Olympus is recalling certain ViziShot 2 FLEX (19G) devices manufactured before May 12, 2025 due to the potential for undetected, deformed a-traumatic tips. These defects could lead to hypotube component ejection, posing a risk during use.
Globally, Olympus has received a total of 91 complaints for the ViziShot 2 FLEX (19G) device, where the laser cut hypotube component has ejected from the device, or plastic components have detached. Of these complaints, 43 were reported to regulators as malfunctions, 40 were reported as serious injury (or potential for serious injury), and 1 was reported for potential contribution to a patient death. |
| Instructions for Customers/Users |
- Olympus does not provide recommendations for medical care in patients who were treated with the impacted devices beyond recommending the standard post-procedural care. However, users of this device should note that for patients with abnormal symptoms or image findings post-procedure, the potential for unanticipated retained device components should be assessed.
- All users of the device are to be aware of the reinforced Cautions and Warnings in the IFU.
- Customers are to quarantine the ViziShot 2 FLEX 19G EBUS-TBNA with the affected lot numbers, which can be found on the Shelf Box or on the Sterile Tray.
- Upon return of the Response Form an Olympus representative will organise the return of affected devices and issue a credit note.
- Devices manufactured after those listed in Appendix A received an automated inspection, which maximised the detection of deformed a-traumatic tips, and therefore are not affected by this recall action. |
| Action Commencement Date |
8/08/2025 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |