| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00091-1 |
| Product Name/Description |
ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F)
Product/Catalogue Numbers (2F): 300240, 300260, 300280, 300240T, 300260T, 300280T
Product/Catalogue Numbers (3F): 300340, 300360, 300380, 300340T, 300360T, 300380T
All Lots/Batches affected
ARTG Number: 168959 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer (ISOMed) has advised that for procedures requiring embolectomy/thrombectomy of arteriovenous (AV) fistulas, the catheter used should have the tensile strength to withstand at least 9N of resistance. After extensive testing, it was determined that the maximum resistances of the ISOMed 2F, 3F & 4F single lumen arterial embolectomy catheters are: 3N, 5N & 9N respectively.
To minimise the risk of vessel damage, balloon rupture or tip detachment in AV fistula procedures, it is recommended that single lumen arterial embolectomy catheters of less than 4F (i.e. 2F & 3F) should not be used for these procedures.
The “Warnings” section of the IFU has been updated to include this information. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medical Specialties Australia is advising users to immediately inspect their stock for affected products. IFUs in the affected stock are to be discarded and replaced with a copy of the updated IFU. This action has been closed-out on 26/05/2017. |
| Contact Information |
02 9417 7955 - Medical Specialties Australia |