Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16069 |
| Brand Name: | Sorin Perceval S Post-Dilation Catheter, Size M |
| Model: | Item: ICV1149 |
| Affected: | 15 lots |
| Software version: | |
| Recalling Organisation: | CARSL Consulting 30 Fulford Road Havelock North 4130 Hastings |
| Contact Information: | 09 238 3447 |
| Manufacturer: | Sorin Group Italia Srl |
| Issue: | In specific models and lots of this device, the blue marker (placed on the catheter shaft close to the balloon proximal extremity, aiding correct position of the balloon with respect to the prosthesis, prior to dilation) may detach and displace during removal of the plastic tube which protects the balloon. Removal of the plastic tube protection may displace the blue marker distal to the balloon. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/1/2014 |
