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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 fo
Recalled December 23, 2015 · FDA recall Z-0437-2016 · Medtronic MiniMed
Hazard
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. · FDA Class II
Units
53 units
Sold at
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 Kingdom.
Description
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.
Product
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.
Manufacturer(s)
Medtronic MiniMed Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →