Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24522 |
| Brand Name: | MitraClip Clip Delivery System, NTR/XTR |
| Model: | Product number CDS0602-XTR |
| 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: | Abbott Vascular (USA) |
| Issue: | The manufacturer has confirmed reports of XTR Clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied to the Clip during implantation. Once the Clip becomes nonfunctional, the inability to close and remove the device has led to surgery or additional intervention. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/5/2019 |
