510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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
FDA enforcement reports joined to recall event Z-2173-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2173-2014Class IITerminatedVoluntary: Firm initiated