Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21834 |
| Brand Name: | FemoSeal |
| Model: | |
| Affected: | All non-expired product Manufactured August 2016 - July 2017 |
| Software version: | |
| Recalling Organisation: | Terumo Australia Pty Ltd (NZ) c/- Healthcare Logistics 56 Carrington Road Mount Albert Auckland 1025 |
| Contact Information: | 0800 66 77 57 |
| Manufacturer: | St Jude Medical Inc |
| Issue: | The manufacturers investigation has identified that the internal suture becomes entrapped as a result of operator misassembly during device manufacture and that this issue then only becoming visible midway through device deployment. Internal controls have been established in manufacturing to eliminate the potential for this defect to recur. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/8/2017 |
