Z-2173-2014Class II
Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
Medtronic, Inc. / initiated 2014-06-16 / Terminated
Medtronic MiniMed Inc. began a recall of Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2173-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medtronic, Inc.
- Product
- Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
- Product code
- FRN Pump, Infusion
- Reason for recall
- 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.
- FDA 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 in commerce
- 764 units
- Distribution
- New Jersey and Worldwide: Belgium, France, Netherland, and Sweden
- Product codes and lots
- n/a
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2173-2014 | Class II | Terminated | Voluntary: Firm initiated |
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