Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24529 |
| Brand Name: | Catheter Introducer |
| Model: | |
| Affected: | Lot Numbers: 61417169, 61446332, 61446333, 61481228, 61481229, 61481230, 61494718 |
| 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 recently become aware of an issue with several lots of lntroFlex lntroducers in which the nylon disk is out of specification. |
| Recall action type: | Correction |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/5/2019 |
