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Recall Observatory FDA recall evidence

Device product

Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D

Z-2173-2014

June 16, 2014

Class II

Product summary

Firm
Medtronic MiniMed Inc.
Event
Event 68633
Status
Terminated
Classification
Class II
Quantity
764 units
Official record key
device-enforcement:Z-2173-2014

Official wording

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.

Code information: n/a

Distribution pattern: New Jersey and Worldwide: Belgium, France, Netherland, and Sweden

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.