Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18564 |
| Brand Name: | Biotronik Pulsar-35 Peripheral Stents, 200mm |
| Model: | Product Codes: 379921, 379941, 379926, 379946, 379931, 379951 |
| Affected: | Selected lot numbers |
| Software version: | |
| Recalling Organisation: | Biotronik Australia Pty Ltd (NZ) 44 Cornwall Park Ave Epsom Auckland 1051 |
| Contact Information: | 0800 246 069 |
| Manufacturer: | Biotronik AG |
| Brand Name: | Biotronik Pulsar-18 Peripheral Stent, 200mm |
| Model: | Product Codes: 366812, 366817, 366822, 366827, 366832, 366837, 366842, 366847 |
| Affected: | Selected lots |
| Software version: | |
| Recalling Organisation: | Biotronik Australia Pty Ltd (NZ) 44 Cornwall Park Ave Epsom Auckland 1051 |
| Contact Information: | 0800 246 069 |
| Manufacturer: | Biotronik AG |
| Issue: | The manufacturer has received a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots of our Pulsar-18 and Pulsar-35 peripheral self-expanding Nitinol stent systems. Potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury or the need to remove the incompletely deployed stent. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/5/2015 |
