Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36352 |
| Brand Name: | Abre Venous Self-Expanding Stent System |
| Model: | Potential for Undersized Stent Diameters in Subset of 12-14mm Stent Lots |
| Affected: | Product number - AB9G14100090 - Batch C134478 |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Inc |
| Issue: | The manufacturer is recalling specific lots of the Abre Venous Self-Expanding Stent System, hereafter referred to as Abre. These specific lots may contain a subset of stents with a smaller-than-expected stent diameter once deployed. Based on internal testing, if a stent is impacted, its inner diameter once deployed averages 0.5 – 0.6mm below historical Abre stents and approximately the same amount smaller than its labelling would indicate. Because of the reduced stent diameter, the associated radial force of the stent will also be reduced by a corresponding amount; other physical stent properties are unaffected by this issue. Although all venous stents pose a risk of migration, an affected lot of Abre stent poses a potentially increased risk that the stent may migrate to the vena cava or right heart/pulmonary vasculature. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/12/2025 |
