Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25855 |
| Brand Name: | LeMaitre_10714_IIa_ Embolectomy Catheter |
| Model: | |
| Affected: | Lots - OTW3190, OTW3821, OTW3958, OTW4073, OTW4197 |
| 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: | The manufacturer has detected an increased trend in reports of catheters failing to deflate during use. The issue occurs if the thread windings around the balloon slip under tension and allow the inflated balloon's proximal attachment to slide over the inflation hole. Under continued tension, the tip of the catheter can begin to stretch, which can lead to tip separation. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/3/2020 |
