PlainRecalls
FDA Devices Moderate Class II Terminated

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 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.

Reported: December 23, 2015 Initiated: September 25, 2015 #Z-0438-2016

Product Description

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 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.

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.

Details

Recalling Firm
Medtronic MiniMed Inc.
Units 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, Luxembourg, Namibia, Netherlands, Norway, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom.
Location
Northridge, CA

Frequently Asked Questions

What product was recalled? ▼
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 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.. Recalled by Medtronic MiniMed Inc.. Units affected: 1052 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2015. Severity: Moderate. Recall number: Z-0438-2016.

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