Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20087 |
| Brand Name: | Intuitive surgical da Vinci S Surgical System |
| Model: | INS-IS2000,INS-IS3000,INS-IS4000 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Intuitive Surgical Inc |
| Issue: | It is detemined that microscopic metallic particulate can be generated during both robotic and non-robotic intra-cardiac surgery. The use of the da Vinci instruments other that the cardiac probe grasper (eg Large Needle Driver) to manipulate a cardiac cryoablation probe during da Vinci cardiac surgery has been shown to increase the amount of microscopic metallic particulate. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/5/2016 |
