Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36538 |
| Brand Name: | Hugo™ Robotically Assisted Surgery (RAS) System |
| Model: | Bipolar Fenestrated Graspers |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Covidien LLC |
| Brand Name: | Surgical Robotics - Bipolar electrosurgical device |
| Model: | Bipolar Maryland Forceps |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Covidien LLC |
| Issue: | Hugo™ robotic-assisted surgery (RAS) system Bipolar Fenestrated Graspers and Bipolar Maryland Forceps, Customer Facing Numbers MRASI0004 and MRASI0005 respectively, have been identified to have an increased likelihood of component failure within the instrument's drive cable pulley assembly due to manufacturing variations. When this failure occurs, the instrument jaw's actuation and articulation will be incorrect, uncontrolled motion may occur, and a visible small white plastic portion of the instrument's pulley component may become disengaged and loose within the patient's cavity. The Hugo™ RAS System will detect this failure and halt telerobotic control of the affected instrument. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/2/2026 |
