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 NumbersPK
2,715 of 2,715 codes
PKK051331RPKK200187RPKK209956RPKK207572RPKK209265RPKK016592RPKK202460RPKK019811RPKK209256RPKK007753RPKK015981RPKK016604RPKK017955RPKK018301RPKK019555RPKK019776RPKK051452RPKK052792RPKK204491RPKK204504RPKK204551RPKK204575RPKK204595RPKK204640RPKK204740RPKK203409RPKK006360RPKK202461RPKK018408RPKK019864RPKK204483RPKK016046RPKK016047RPKK019820RPKK020201RPKK010563RPKK209937RPKK209928RPKK050581RPKK209305RPKK211241RPKK209294RPKK201567RPKK206687RPKK211282RPKK208961RPKK209373RPKK202996RPKK210858RPKK202566RPKK211233RPKK205628RPKK209203RPKK211710RPKK100124RPKK211042RPKK210807RPKK200224RPKK208864RPKK209197R
- Serial Numbers
- 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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