| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00538-1 |
| Product Name/Description |
Venture RX, OTW and CS Catheters
Venture RX
Model Number: 5820
Venture OTW
Model Number: 5821
Venture CS
Model Number: 5882
Multiple Lot Numbers
Supplied under Special Access Scheme (SAS) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Vascular Solutions (VSI), through an internal investigation has concluded there is the potential for excess material used to manufacture specific Venture catheters to be present within the inner lumen of the distal catheter tip. It is possible that the excess material may separate from the catheter during a procedure, posing a potential risk of an embolism to the patient. To date, the manufacturer has received no reports of adverse patient events related to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Pyramed is advising users to immediately cease use of and quarantine the affected units. Pyramed will arrange for the return of affected devices and credit for unused devices after their return.
This action has been closed out on 31/10/2018 |
| Contact Information |
07 5593 1183 - Pyramed |