MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump

FDA device recall Z-0438-2016 · posted 2015-12-17 · Terminated

Recall details

Recalling firm

Medtronic MiniMed Inc.

Reason for recall

The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Possible cause is either lack of greasing or deficient greasing in a ball bearing assembly of the motor.

Action taken

Medtronic sent an Urgent Medical Device Recall Notification dated September 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters stated that the pump drive motors may experience a malfunction which would result in a pump error message alarm notifying the patient that insulin is no longer being delivered. The letters also inform the customers of what actions are to be taken. Customers with questions are instructed to contact Medtronic MiniMed's customer support team. For further questions please call (818) 576-4700.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

OYC

Quantity affected

1052 units

Distribution

Internationally Distribution only to the countries of : Australia, Austria, Belgium, Chile, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Italy, Japan, Kenya, Lux

Date initiated

2015-09-25

Date posted

2015-12-17

Date terminated

2016-02-05

Location

Northridge, CA