Medtronic MiniMed Inc. recalls MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for…

Recall date

September 25, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0437-2016

FDA classification

Class II

Brand / firm

Medtronic MiniMed Inc.

Sold / distributed

Internationally Distribution only to the countries of : Australia, Austria, Belgium, Chile, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Italy, Japan, Kenya, Luxembourg, Namibia, Netherlands, Norway, Slovenia, South Africa, Spain, Sweden, Switzerland, United K…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes.