The Recall Desk

FDA (Devices) recall action 84430

Medtronic Inc. recalled 4 products on 2020-02-19

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2020-02-19
Critical
0
Units
—

Why these products were recalled

There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.

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

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2020-02-19

    Medtronic MiniMed 670G System Recalled for Loose Insulin Reservoir

    Medtronic is recalling MiniMed 670G Systems with SmartGuard because a broken or missing retainer ring can cause the insulin reservoir to become loose, leading to incorrect insulin delivery.

    Product
    Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MMT-1782
    Category
    Distribution
    52 states
  • SevereFDA (Devices)··2020-02-19

    Medtronic MiniMed 640G Insulin Pump Recall for Loose Reservoir Risk

    Medtronic is recalling specific 640G insulin pumps due to a loose reservoir that may cause incorrect insulin delivery.

    Product
    Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US Distribution
    Category
    Distribution
    52 states
  • HighFDA (Devices)··2020-02-19

    Medtronic MiniMed 630G System Recalled for Loose Reservoir Defect

    Medtronic is recalling MiniMed 630G Systems with SmartGuard because a broken or missing retainer ring can cause the insulin reservoir to become loose, leading to incorrect insulin delivery.

    Product
    Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
    Category
    Distribution
    52 states
  • HighFDA (Devices)··2020-02-19

    Medtronic MiniMed 620G Insulin Pump Recall for Loose Reservoirs

    Medtronic is recalling MiniMed 620G insulin pumps not distributed in the US due to a loose reservoir that may cause incorrect insulin delivery.

    Product
    Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US
    Category
    Distribution
    52 states