Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21089 |
| Brand Name: | LeMaitre_14339_IIa_Valvulotome |
| Model: | |
| Affected: | Lot # ELVH1103V |
| Software version: | |
| Recalling Organisation: | Clinical & Regulatory Services Limited 30 Fulford Road Havelock North Hastings 4130 |
| Contact Information: | (06) 844 4490 |
| Manufacturer: | LeMaitre Vascular Inc |
| Issue: | There have been issues of hoops failing to close when the device was actuated. In some cases, this issue has been discovered in-use and has led to vessel damage. If the blades are stuck in the open position, the device must be removed in the open state. The removal of the device without sheathing may cause damage to the vein either during use or when the blades pass the opening of the vessel. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 9/2/2017 |
