Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20237 |
| Brand Name: | TCVS Heart lung machine |
| Model: | 802018 |
| Affected: | System Flow Module |
| Software version: | |
| Recalling Organisation: | Terumo Australia Pty Ltd (NZ) c/- Healthcare Logistics 56 Carrington Road Mount Albert Auckland 1025 |
| Contact Information: | 0800 66 77 57 |
| Manufacturer: | Terumo Cardiovascular Systems Corp |
| Issue: | Terumo Cardiovascular Systems (CVS) received reports of random flow readings and/or intermittent false back flow alarms for the Terumo Advanced Perfusion System. 1. There was no tubing in the flow sensor. When operating as intended, the module will generate '---' (three dashes) in the display, and issue a 'check sensor' alert message, when there is no tubing in the flow sensor |
| Recall action type: | Correction |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/6/2016 |
