Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20239 |
| Brand Name: | TCVS Heart lung machine |
| Model: | Serial interface module RS-232, Serial interface module RS-485, Interface module for CDI System 100/101, Interface module for CDI System 500 |
| Affected: | Interface 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 (Terumo CVS) has received reports of malfunctions between 2006 and 2010 involving the loss of data transfer capabilities. Some reports stated that the odor of smoke was associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. Terumo CVS' investigation has determined that the malfunctions are caused by a circuit board that failed. |
| Recall action type: | Correction |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/6/2016 |
