Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19857 |
| Brand Name: | Biosensors Biomatrix Flex Drug Eluting Stent |
| Model: | BMX-3511, BMX-3518, BMX-3524, BMX-4018 |
| Affected: | Batches : K15100000 K15100011 K15110086 K15110054 K15100017 K1510017 K15110058 W15110058 |
| Software version: | |
| Recalling Organisation: | InterMed Medical Ltd 71 Apollo Drive Albany AUCKLAND 1311 |
| Contact Information: | 0800 333 444 |
| Manufacturer: | Biosensors Europe SA |
| Brand Name: | BioSensors_BioMatrix NeoFlex Drug Eluting Coronary Stent System |
| Model: | BMXP-3511, BMXP-3518, BMXP-4018, BMXP-4024 |
| Affected: | Batches: W15100548 W15100236 W15100237 W15100238 W15110086 W15120234 |
| Software version: | |
| Recalling Organisation: | InterMed Medical Ltd 71 Apollo Drive Albany AUCKLAND 1311 |
| Contact Information: | 0800 333 444 |
| Manufacturer: | Biosensors Europe SA |
| Issue: | Manufacturer discovered during routine lot release testing that several production lots did not meet the balloon rated burst performance specifications. After full investigation, manufacturer concluded that the compromised balloon performance was caused by certain characteristics in the manufacturing process. Biosensors positively identified production lots manufactured between October to December 2015 that could have been similarly affected. The compromised balloon performance may potentially lead to delay in inflation or deflation of the balloon; or balloon burst when the balloon is inflated above the nominal pressure. This could result in procedural complications and lead to serious deterioration in the patient's state of health during PCI. Patients who have already been implanted with an affected device are not impacted by this field safety corrective action. No field complaint or patient injury has been reported associated with the compromised balloon performance. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 7/3/2016 |
