Recall Z-1007-2007 ยท LZG Pump, Infusion, Insulin
Medtronic MiniMed
Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722
| Date | Jul 7, 2007 (initiated Apr 27, 2007) |
| Status | Terminated |
| Reason | Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemi |
| Root cause | Other |
| Action | Firm mailed Medical Device Safety letters on April 24, 2007, to healthcare professionals, existing pump users and MRI facilities reiterating the existing warning in the pump User Guide to avoid exposing the pump to MRI (or similar high strength electromagnetic fields) and strengthening previous warning by specifically mentioning the potential for over-delivery and severe hypoglycemia. Firm is also including an insert with this information with any Paradigm infusion pumps shipped to new customers. |
| Quantity | 334,000 Paradigm insulin pumps (approx) |
| Distribution | Worldwide: USA, US Virgin Islands, Antigua, Australia, Austria, Bahamas, Bahrain, Bermuda, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, |
| 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 |
| K030531 | MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER Minimed, Inc., Jun 17, 2003 |
| K031390 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712 Minimed, Inc., Jul 23, 2003 |
| K040676 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715 Medtronic Minimed, May 21, 2004 |
| K053177 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E Medtronic Minimed, Jan 31, 2006 |