Recall Z-2173-2014 ยท FRN Pump, Infusion
Medtronic MiniMed Inc.
Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
| Date | Aug 8, 2014 (initiated Jun 16, 2014) |
| Status | Terminated |
| Reason | Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of the delivery of insulin prior to the end of the 7 year useful life of the device. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Field Safety Notice Letter dated 6/16/14 was sent to all customers who purchased the Medtronic Implantable Insulin Pump. The letter informs the customers of the problems identified and the actions to be taken. Customers are informed that Medtronic MiniMed is working to make new unaffected pumps available as soon as possible. Customers are instructed to contact Elisabeth Andrieu at + 33 6 89 71 9056 or Dr. Francine Kaufman at +1 818.576.5331. |
| Quantity | 764 units |
| Distribution | New Jersey and Worldwide: Belgium, France, Netherland, and Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.