The Recall Desk

FDA (Devices) recall action 87662

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled 4 products on 2021-05-12

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
2021-05-12
Critical
0
Units
963,224

Why these products were recalled

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

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)··2021-05-12

    Medtronic Recalls CRT-P Pacemakers Due to Longevity Estimation Error

    Medtronic is recalling specific implantable cardiac resynchronization therapy pacemakers because a longevity estimation error may occur in the early years of device life.

    Product
    Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta CR
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-05-12

    Medtronic Programmers Recalled for Longevity Estimation Error

    Medtronic is recalling 2090 Carelink and 29901 Encore programmers due to a potential longevity estimation error in specific pacing configurations.

    Product
    Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-05-12

    Medtronic Recalls CareLink SmartSync Device Manager for Longevity Error

    Medtronic is recalling 16,311 CareLink SmartSync Device Manager units worldwide due to a potential longevity estimation error when specific pacing vectors are programmed.

    Product
    CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2021-05-12

    Medtronic Recalls Implantable Pulse Generators Due to Longevity Estimation Error

    Medtronic is recalling implantable pulse generators because a longevity estimation error may occur in early device life when specific pacing vectors are programmed.

    Product
    Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI SureSca
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    0 states