Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26925 |
| Brand Name: | SIS-Medical - PTCA Balloons |
| Model: | |
| Affected: | Multiple lot numbers |
| Software version: | |
| Recalling Organisation: | Lifehealthcare Ltd New Zealand Unit E 61 Hugo Johnston Drive Penrose Auckland 1642 |
| Contact Information: | |
| Manufacturer: | Schwager Medica AG |
| Issue: | The manufacturer, has elected to change the Rated Burst Pressure (RBP) of the OPN NC Super High Pressure PTCA Balloon. This change sees the RBP be reduced from 35 atm to 32 atm. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/11/2020 |
