The Recall Desk

FDA (Devices) recall action 87261

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled 2 products on 2021-04-07

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
2021-04-07
Critical
0
Units
528,479

Why these products were recalled

A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2021-04-07

    Medtronic Recalls Implantable Cardioverter Defibrillators Due to Shortened Replacement Time

    Medtronic is recalling specific Evera and Visia ICD models because a small percentage may experience a shortened Recommended Replacement Time to End of Service interval.

    Product
    Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Impla
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2021-04-07

    Medtronic Recalls CRT-D Devices Due to Shortened Replacement Time

    Medtronic is recalling specific CRT-D implantable cardioverter defibrillators because a small percentage may experience a shortened time before the device reaches end of service.

    Product
    Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3)
    Category
    Distribution
    1 state