Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22080 |
| Brand Name: | Medtronic FlexCath Advance Steerable Sheath |
| Model: | 4FC12 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Cryocath LP |
| Issue: | Medtronic has supplemented the FlexCath Advance Steerable Sheath IFU to highlight the known risk of air embolism more prominently. Air embolism is a known risk for patients undergoing percutaneous interventions requiring access to the left atrium, such as ablation procedures.These updates do not impact current clinical practice as this information is consistent with current training and education materials. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/10/2017 |
