The Recall Desk

FDA (Devices) recall action 65443

Medtronic Neuromodulation recalled 2 products on 2013-07-03

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
2013-07-03
Critical
0
Units
522,218

Why these products were recalled

Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und

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)··2013-07-03

    Medtronic SynchroMed EL Pumps Recalled for Electrical Shorting Risk

    Medtronic is recalling SynchroMed EL pumps due to potential internal electrical shorting that may cause therapy loss.

    Product
    Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific s
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-07-03

    Medtronic SynchroMed II Pumps Recalled for Electrical Shorting Risk

    Medtronic is recalling SynchroMed II pumps due to potential electrical shorting that may cause therapy loss or reduction.

    Product
    Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the Syn
    Category
    Distribution
    0 states