| TGA Action ID |
RC-2026-RN-00642-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Imager II Angiographic Catheters
All Lot Numbers
Multiple Inner and Outer Package UPNs
Expiration Dates: 08/10/2026 - 09/06/2028 |
| ARTG Number |
433411 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Boston Scientific is initiating an urgent recall of Imager II Angiographic Catheters due to a manufacturing problem affecting the catheter tip. Boston Scientific has determined that these Catheters were manufactured with reduced levels of stabilising agents in the tips. This may increase the risk of tip degradation and detachment.
Although no increase in tip detachment complaints has been identified for the affected lots, the devices were manufactured outside the approved design specification and are being recalled from the market.
The most common adverse health consequence of tip detachment in the intravascular space is a delay in procedure to exchange for a new device. The most serious potential adverse health consequence within the intravascular space is life threatening embolism resulting from a device fragment obstructing blood flow resulting in end organ failure. |
| Instructions for Customers/Users |
Customers are to:
- Immediately stop further use or distribution and quarantine the affected product.
- Return the affected product to Boston Scientific in accordance with the instructions in the Customer Letter.
- Continue to follow the standard of care when monitoring patients treated with the product. |
| Action Commencement Date |
21/08/2026 |
| Responsible Entity |
|
| Contact Information |
anz_incident_report@bsci.com - Boston Scientific |