Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24096 |
| Brand Name: | Catheter, cardiac, balloon, thermal dilution |
| Model: | |
| Affected: | Lot number: 61321241 |
| Software version: | |
| Recalling Organisation: | Edwards Lifesciences (New Zealand) Limited 171 Morrin Road St John Auckland 1072 |
| Contact Information: | 021 313 234 |
| Manufacturer: | Edwards Lifesciences LLC |
| Issue: | The manufacturer has become aware of an issue that involves Swan Ganz catheters with incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms. It is possible for unintended treatment due to inaccurate values if the reversal in waveform is not noticed. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/1/2019 |
