The Recall Desk

FDA (Devices) recall action 97130

Medtronic, Inc. recalled 2 products on 2025-07-30

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
2025-07-30
Critical
0
Units
44,182

Why these products were recalled

In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

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)··2025-07-30

    CareLink SmartSync limited the window to abort a high voltage therapy

    Medtronic CareLink SmartSync Device Manager is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.

    Product
    Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Mod
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-07-30

    SmartSync Patient Connector limited the window to abort high voltage therapy

    The Medtronic CareLink SmartSync Patient Connector is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.

    Product
    Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software M
    Category
    Distribution
    0 states