Recall Z-0010-05 ยท LZG Pump, Infusion, Insulin
Medtronic MiniMed
Medtronic MiniMed Paradigm Model 712
| Date | Sep 14, 2004 |
| Status | Terminated |
| Reason | Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish. |
| Root cause | Other |
| Quantity | 10,600 |
| Distribution | Nationwide & Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030531 | MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER Minimed, Inc., Jun 17, 2003 |