The Recall Desk

FDA (Devices) recall action 72352

Medtronic MiniMed Inc. recalled 2 products on 2015-12-23

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-12-23
Critical
0
Units
1,105

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2015-12-23

    Medtronic MiniMed 620G Insulin Pump Recall for Motor Malfunction

    Medtronic is recalling 53 MiniMed 620G insulin pumps because a motor malfunction may stop insulin delivery. The issue involves a ball bearing assembly.

    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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-12-23

    Medtronic MiniMed 640G Insulin Pumps Recalled for Motor Malfunction

    Medtronic MiniMed is recalling 1,052 MiniMed 640G insulin pumps due to a potential drive motor malfunction that could stop insulin delivery.

    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…
    Category
    Distribution
    0 states