Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36467 |
| Brand Name: | Endoscopic electrosurgical handpiece |
| Model: | Model: KD-V411M & KD-V431M - CleverCut 3V Single Use 3-Lumen Sphincterotome V |
| Affected: | Multiple lots |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Olympus Medical Systems Corporation |
| Brand Name: | Andotherapy device, active, single-use |
| Model: | Model: KD-VC411Q & KD-VC431Q - CleverCut 3V Single Use Sphincterotome V (Distal Wireguided) with C-Channel |
| Affected: | Multiple lots |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Olympus Medical Systems Corporation |
| Issue: | The manufacturer has observed an increase in complaints regarding wire deformation in the CleverCut 3V Sphincterotome devices. Preliminary investigations showed that units manufactured with a thermoforming process, which involves heating the assembly, so the device tip keeps the curved stylet's shape, are less likely to have an incorrect cutting wire orientation. Devices which did not undergo thermoforming could deform and lose performance. As a result, the manufacturer is removing lots where the devices may not have been manufactured with the thermoforming process. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/1/2026 |
