Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15666 |
| Brand Name: | Boston Scientific Vessix generator System |
| Model: | RDBS010 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Vessix Vascular Inc |
| Issue: | The manufacturer is initiating a Recall of the Vessix™ Generator System. An investigation has found that the units manufactured since 2013-04 (April 2013) were not manufactured according to specification. This manufacturing issue may cause an electrical short in the generator. To date, there have been no reports of patient injury. While there are no reports of patient injury, the issue could result in excessive RF energy being delivered to the renal artery. The potential health hazards associated with the delivery of excessive RF energy include thrombosis formation, nerve damage and thermal damage to the renal artery or adjacent structures. This Recall affects the generator only and does not impact the Vessix™ Renal Denervation Catheters or any other components of the system. . |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/11/2013 |
