Reported Feb 13, 2019 · Terminated

MEDTRONIC CARELINK 2090 programmer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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 Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391

Is this the product you have?

  • MEDTRONIC CARELINK 2090 programmer
Lot codes and dates
  • UPN Lot Serial #

    2,413 of 2,413 codes

    • 00613994175397
    • PKK005256R
    • 00721902246241
    • PKK005435R
    • 00613994175380
    • PKK010235R
    • 00613994136541
    • PKK010864R
    • 00613994175106
    • PKK010944R
    • 00613994175106
    • PKK013390R
    • 00613994175076
    • PKK014053R
    • 00721902171079
    • PKK014459R
    • 00721902246241
    • PKK016196R
    • 00613994581594
    • PKK019007R
    • 00613994175397
    • PKK053072R
    • 00613994175397
    • PKK053799R
    • 00885074314921
    • PKK100200R
    • 00885074301440
    • PKK100970R
    • 00885074312873
    • PKK101320R
    • 00885074312866
    • PKK101390R
    • 00885074312873
    • PKK101826R
    • 00613994175144
    • PKK102639R
    • 00885074313122
    • PKK104915R
    • 00613994175250
    • PKK106350R
    • 00613994434982
    • PKK200802R
    • 00613994435309
    • PKK200982R
    • 00613994435309
    • PKK201102R
    • 00613994434937
    • PKK203476R
    • 00613994434937
    • PKK203505R
    • 00613994580894
    • PKK204058R
    • 00613994580962
    • PKK204433R
    • 00613994580887
    • PKK205733R
    • 00613994580924
    • PKK205784R
    • 00613994580894
    • PKK206708R
Amount recalled
33007 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).

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 Feb 2, 2021 · Data as of Sep 19, 5:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.