Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14584 |
| Brand Name: | FlexStent Femoropopliteal Self-Exanding Stent System |
| Model: | |
| Affected: | all lots |
| Software version: | |
| Recalling Organisation: | Endoventure Ltd 2/1 Esmonde Road Takapuna Auckland |
| Contact Information: | |
| Manufacturer: | Flexible Stenting Solutions Inc |
| Issue: | Manufacturer has determined that during internal package integrity testing, following transportation simulation challenge, the sterile barrrier of the pouch (inner pouch) of some units of the FlexiStent could be compromised.and to a lesser degree, the outer pouch. To date no complaints associated with this potential mode of failure have been reported. In the event a hole or a tear in the clear film side of the pouch of the affected product is present and both pouches are affected, loss of the sterile barrier could occur, leading to use of a non-sterile device in the procedure. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/5/2013 |
