Reported Nov 6, 2019 · Ongoing

Programmers & Remote Monitoring Software Apps: 2090 CareLink 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?

  • Programmers &
  • Remote Monitoring Software Apps2090 CareLink Programmer
Lot codes and dates
  • Serial Numbers

    2,715 of 2,715 codes

    • PKK051331R
    • PKK200187R
    • PKK209956R
    • PKK207572R
    • PKK209265R
    • PKK016592R
    • PKK202460R
    • PKK019811R
    • PKK209256R
    • PKK007753R
    • PKK015981R
    • PKK016604R
    • PKK017955R
    • PKK018301R
    • PKK019555R
    • PKK019776R
    • PKK051452R
    • PKK052792R
    • PKK204491R
    • PKK204504R
    • PKK204551R
    • PKK204575R
    • PKK204595R
    • PKK204640R
    • PKK204740R
    • PKK203409R
    • PKK006360R
    • PKK202461R
    • PKK018408R
    • PKK019864R
    • PKK204483R
    • PKK016046R
    • PKK016047R
    • PKK019820R
    • PKK020201R
    • PKK010563R
    • PKK209937R
    • PKK209928R
    • PKK050581R
    • PKK209305R
    • PKK211241R
    • PKK209294R
    • PKK201567R
    • PKK206687R
    • PKK211282R
    • PKK208961R
    • PKK209373R
    • PKK202996R
    • PKK210858R
    • PKK202566R
    • PKK211233R
    • PKK205628R
    • PKK209203R
    • PKK211710R
    • PKK100124R
    • PKK211042R
    • PKK210807R
    • PKK200224R
    • PKK208864R
    • PKK209197R
    PK
Amount recalled
29544 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Why it was recalled

There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.

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

Data as of Sep 19, 4:44 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.