Reported Jul 17, 2013 · Terminated

Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin…

Medtronic MiniMed

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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 Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
Lot codes and dates
  • This field correction involves models
    • MMT-317
    • MMT-318
    • MMT-324
    • MMT-325
    • MMT-312S
    • MMT-312L
    • MMT-386
    • MMT-387
    • MMT-394
    • MMT-396
    • MMT-397
    • MMT-398
    • MMT-399
    • MMT-377
    • MMT-378
    • MMT-381
    • MMT-382
    • MMT-383
    • MMT-384
    • MMT-368
    • MMT-862
    • MMT-864
    • MMT-866
    • MMT-874
    • MMT-876
    • MMT-884
    • MMT-886
    • MMT-921
    • MMT-923
    • MMT-925
    • MMT-941
    • MMT-943
    • MMT-945
    • MMT-961
    • MMT-963
    • MMT-965
    • & MMT-975 Paradigm Infusion sets
Amount recalled
11,000,000 units

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 10, 2015 · Data as of Sep 19, 4:49 PM UTC

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