Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19733 |
| Brand Name: | Evalve MitraClip |
| Model: | SGC01ST |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Abbott Vascular Division of Abbott Laboratories (NZ) Ltd Ground Floor, Building D 4 Pacific Rise Mount Wellington Auckland 1060 |
| Contact Information: | 0800 827 285 |
| Manufacturer: | Evalve Inc |
| Brand Name: | Evalve Mitraclip Clip Delivery System (CDS) |
| Model: | MSK02ST |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Abbott Vascular Division of Abbott Laboratories (NZ) Ltd Ground Floor, Building D 4 Pacific Rise Mount Wellington Auckland 1060 |
| Contact Information: | 0800 827 285 |
| Manufacturer: | Evalve Inc |
| Issue: | Manufacturer has recently received reports of cases in Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitralClip but the Clip could not be detached from the delivery system due to a mandrel fracture. These cases resulted in severe surgical interventions and in one case the patient died post-operatively due to severe comorbidities. Current Instructions for Use (IFU) require the Arm Positioner to be in a Neutral position prior to turning the Actuator Knob to deploy the Clip; manufacturerr is revising the MitraClip IFU Clip deployment sequence to provide additional assurance that tension is completely eliminated prior to deploying the Clip. Abbott Vascular will train all MitraClip implanters on the revised instructions. Note : Currently, there are no MitraClip systems in New Zealand. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 5/2/2016 |
