The Recall Desk

FDA (Devices) recall action 86887

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled 3 products on 2021-02-03

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2021-02-03
Critical
0
Units
6

Why these products were recalled

Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.

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

1–3 of 3

  • HighFDA (Devices)··2021-02-03

    Medtronic Cobalt DR MRI SureScan Defibrillators Recalled for Potential Loss of Function

    Medtronic is recalling two specific MRI SureScan defibrillators because a component failure could cause the device to lose function.

    Product
    Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2021-02-03

    Medtronic Cobalt HF CRT-D MRI SureScan Recall for Potential Loss of Function

    Medtronic is recalling two specific Cobalt HF CRT-D MRI SureScan devices due to a rare failure mechanism that could cause loss of function.

    Product
    Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
    Category
    Distribution
    3 states
  • SevereFDA (Devices)··2021-02-03

    Medtronic COBALT HF QUAD CRT-D MRI SureScan Recall for Potential Loss of Function

    Medtronic is recalling two specific COBALT HF QUAD CRT-D MRI SureScan devices due to a rare component failure mechanism that could cause loss of function.

    Product
    Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
    Category
    Distribution
    3 states