Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23303 |
| Brand Name: | Sorin/Perceval Sutureless Aortic Valve |
| Model: | Perceval Sutureless Aortic Heart Valve size S, Perceval Sutureless Aortic Heart Valve size M, Perceval Sutureless Aortic Heart Valve size L, Perceval Sutureless Aortic Heart Valve size XL |
| Affected: | |
| Software version: | |
| Recalling Organisation: | CARSL Consulting 30 Fulford Road Havelock North 4130 Hastings |
| Contact Information: | 09 238 3447 |
| Manufacturer: | Sorin Group Italia Srl |
| Issue: | The manufacturer has recently become aware, through its post-market surveillance processes, of more than anticipated cases of valve insufficiency, primarily caused by oversizing leading to "stent folding". |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 6/7/2018 |
