The Recall Desk

FDA (Devices) recall action 82078

Medtronic Inc. recalled 2 products on 2019-11-13

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
2019-11-13
Critical
0
Units
231,732

Why these products were recalled

There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.

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

  • SevereFDA (Devices)··2019-11-13

    Medtronic Recalls MiniMed Model 500 Remote Controls for Security Vulnerability

    Medtronic is recalling MiniMed Model 500 Remote Controls used with the MiniMed 508 Insulin Pump due to a potential security vulnerability.

    Product
    Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-11-13

    Medtronic Recalls MiniMed Remote Transmitters for Security Vulnerability

    Medtronic is recalling MiniMed Model 503 Remote Transmitters due to a potential security vulnerability affecting insulin pump accessories.

    Product
    Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm Insulin Pump (MMT-523/723, MMT-523K/723K, MMT-551/751, MMT-554/754, MMT-522/722, MMT-522K/722K, MMT-515/715, MMT-512/712, MMT-511)
    Category
    Distribution
    0 states