| TGA Action ID |
RC-2026-RN-00473-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
NephroMax High Pressure Nephrostomy Balloon Catheters
Descriptions: NEPHROMAX 10-12/7/55, NEPHROMAX BALLOON KIT 30F W/17CM PTFE SH, NEPHROMAX 8-12/7/55, NEPHROMAX CLEAR 10-12/7/55,
NEPHROMAX 10-15/7/55, NEPHROMAX BALLOON KIT 24F W/17CM PTFE SH, NEPHROMAX BALLOON KIT 30F W/17CM PTFE CS, NEPHROMAX BALLOON KIT 30F W/20CM PTFE SH
Multiple material and lot numbers
Expiry Date: 30 June 2028 - 19 October 2028 |
| ARTG Number |
149646, 211738 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The renal sheath for certain NephroMax High Pressure Nephrostomy Balloon Catheters may be packaged in a reversed orientation.
If the sheath orientation is not corrected prior to use, this could increase resistance and result in difficulty advancing, withdrawing or positioning the catheter. |
| Instructions for Customers/Users |
Customers are to:
- Inspect the product before use, verify renal sheath orientation and correct if necessary.
If increased resistance is experienced during advancement or manipulation, stop, reassess, and correct the problem. Do not continue forceful manipulation. |
| Action Commencement Date |
24/06/2026 |
| Responsible Entity |
|
| Contact Information |
anz_incident_report@bsci.com - Boston Scientific |