Recall Z-0168-04 ยท LZG Pump, Infusion, Insulin
Medtronic MiniMed
Paradigm Model 511 and 512 Insulin Infusion Pumps
| Date | Nov 27, 2003 (initiated Aug 29, 2003) |
| Status | Terminated |
| Reason | Water ingresses into the device when in prolonged contact with water causing device to malfunction. |
| Root cause | Other |
| Action | The firm sent notifications to all pump users of record, all distributors and all certified pump trainers indications that the pumps should not be immersed in water. Canadian users were contacted by Medtronic Canada. |
| Quantity | Approximately 61,000 patients |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001829 | MINIMED PARADIGM INSULIN PUMP, MODEL 511 Minimed, Inc., Aug 18, 2000 |