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

FDA device recall Z-2173-2014 · posted 2014-08-08 · Terminated

Recall details

Recalling firm

Medtronic MiniMed Inc.

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.

Action taken

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

Status

Terminated

Product code

FRN

Quantity affected

764 units

Distribution

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

Date initiated

2014-06-16

Date posted

2014-08-08

Date terminated

2014-09-25

Location

Northridge, CA