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Terminated

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

FDA Recall Z-2173-2014 · Posted 2014-08-08

Recalling FirmMedtronic MiniMed Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2014-06-16
Date Terminated2014-09-25
Product Quantity764 units

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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