Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24364 |
| Brand Name: | Septostomy |
| Model: | |
| Affected: | All lots within 15 months expiry |
| Software version: | |
| Recalling Organisation: | Edwards Lifesciences (New Zealand) Limited 171 Morrin Road St John Auckland 1072 |
| Contact Information: | 021 313 234 |
| Manufacturer: | Edwards Lifesciences LLC |
| Issue: | The manufacturer has identified a potential risk, which may occur during the use of the Miller and Fogarty atrioseptostomy catheters. While the Instructions for Use detail the preparation for use of the product, including inflation and deflation of the balloon to verify functionality, however have still received reports regarding difficulty in balloon deflation after deployment, and reports of balloon fragmentation or detachment, which has the potential to lead to additional complications. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/3/2019 |
