Reported Apr 17, 2013 · Terminated

Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715,…

Medtronic MiniMed

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic MiniMed · 18000 Devonshire St · Northridge, CA · 91325-1219

Is this the product you have?

  • Medtronic MiniMed Paradigm
  • Insulin Infusion Pumps Model Numbers
    • MMT-511
    • MMT-512
    • MMT-712
    • MMT-712E
    • MMT-515
    • MMT-715
    • MMT-522
    • MMT-522K
    • MMT-722
    • MMT-722K
    • MMT-523
    • MMT-523K
    • MMT-723
    • MMT-723K
    • MMT-554
    • and MMT-754
  • Product UsageParadigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes
Lot codes and dates
  • Not available
Amount recalled
428,000 units

Where it was sold

Why it was recalled

Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is expose to water it may result in damage to the pump's internal electronics. This moisture damage can prevent the pump's buttons from working properly or can cause the pump to alarm.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 4, 2013 · Data as of Sep 19, 6:50 PM UTC

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