The Recall Desk

FDA (Devices) recall action 80433

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled 4 products on 2018-07-18

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
2018-07-18
Critical
0
Units
13,718

Why these products were recalled

Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).

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.

1–4 of 4

  • HighFDA (Devices)··2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Devices Recalled for Potential Reset

    Medtronic is recalling Percepta CRT-P MRI SureScan devices due to a potential device reset caused by a timing interaction between specific diagnostic and pacing features.

    Product
    Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Devices Recalled for Potential Reset

    Medtronic is recalling Percepta CRT-P MRI SureScan devices due to a timing interaction that may cause a device reset.

    Product
    Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Recall for Device Reset Risk

    Medtronic is recalling 1,842 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.

    Product
    Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Recall for Device Reset Risk

    Medtronic is recalling 1,604 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.

    Product
    Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive…
    Category
    Distribution
    0 states