Recall Z-0438-2016— Medtronic MiniMed Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic MiniMed Inc., initiated 2015-09-25, terminated 2016-02-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Medtronic MiniMed Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-25
- Terminated
- 2016-02-05
- Firm location
- Northridge, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.