| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00298-1 |
| Product Name/Description |
Neuroform Atlas Stent System
(Used with occlusive devices in the treatment of intracranial aneurysms)
Item numbers: EZAS3024, EZAS3015, EZAS4015, EZAS4530, EZAS3021, EZAS4521 and EZAS4024.
All lot numbers
Supplied under the Special Access Scheme |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Stryker Neurovascular has become aware that the product labels (pouch and carton) for the Neuroform Atlas Stent Catheter contains an incorrect conversion from inches to millimetres for the Minimum Catheter Diameter dimension (0.0165in 0.69 mm). The correct dimensions are 0.0165in (0.42mm).
This labelling discrepancy could lead to a physician selecting a catheter which is too large. The hazard associated with this is that the stent would prematurely deploy during transfer into the catheter. If this happens, additional procedure/treatment would be required and the patient may be exposed to increased time under anaesthesia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is advising that the affected devices can continue to be used, provided that the correct dimensions listed in the product directions for use (DFU) are followed. This action has been closed-out on 23/01/2017. |
| Contact Information |
02 9467 1175 - Stryker |