Reported Aug 28, 2013 · Terminated

Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A…

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 Reservoirs
  • Model NoMMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669,672 units
Lot codes and dates
  • MMT-326A Lot Numbers
    • H8437486
    • H8441420
    • H8442973
    • H8451531
    • H8486688
    • H8489386
    • H8485398
    • H8500423
    • H8500472
    • H8503728
    • H8512826
    • H8503372
    • H8510440
  • H8539013 H8627745 MMT-332A Lot Numbers
    • H8416432
    • H8420977
    • H8422490
    • H8424676
    • H8452933
    • H8455959
    • H8457716
    • H8459557
    • H8461538
    • H8463297
    • H8464121
    • H8467888
    • H8469703
    • H8471745
    • H8473271
    • H8476270
    • H8478398
    • H8473106
    • H8492449
    • H8491921
    • H8494645
    • H8496561
    • H8509305
    • H8512566
    • H8515317
    • H8517079
    • H8521052
    • H8541843
    • H8584244
    • H8603292
    • H8604958
    • H8635301
Amount recalled
669,672 units

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not

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 Jan 16, 2014 · Data as of Sep 19, 6:07 PM UTC

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