| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01498-1 |
| Product Name/Description |
Malecot Nephrostomy Catheter Set
Material Numbers: M0064101000, M0064101010
All batch number are affected
ARTG Number: 125167 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific (BSC) is initiating a removal of certain Malecot Nephrostomy Catheters due to reports of some catheters breaking at the mid-shaft bond during use. The bond is located where the renal end of the Malecot catheter is bonded to the catheter shaft. BSC has received seventeen (17) complaints for this issue since December 1, 2013. There have been no injuries reported as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Boston Scientific is advising users to inspect stock and quarantine any remaining units of the affected product. Stock can be returned to Boston Scientific for credit.
This action has been closed out on the 25/10/2018. |
| Contact Information |
1800 676 133 - Boston Scientific Customer Service |