Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14399 |
| Brand Name: | AMS 800 Artificial Urinary Sphincter Control Pumps |
| Model: | Item numbers: 72400098 and 72404127 |
| Affected: | multiple serial numbers |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | American Medical Systems Inc |
| Issue: | A review of manufacturing records has revealed that some control pumps produced at AMS were released despite not meeting all final product release criteria. |
| Recall action type: | Alert |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 5/4/2013 |
