Reported Nov 6, 2019 · Ongoing
Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore 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 Apps29901 CareLink Encore Programmer
- Lot codes and dates
- Serial NumbersJVD
2,715 of 2,715 codes
JVD000209PJVD000233PJVD000242PJVD000243PJVD000244PJVD000245PJVD000246PJVD000247PJVD000248PJVD000249PJVD000250PJVD000251PJVD000252PJVD000253PJVD000254PJVD000255PJVD000256PJVD000257PJVD000258PJVD000259PJVD000260PJVD000261PJVD000262PJVD000263PJVD000264PJVD000265PJVD000266PJVD000267PJVD000269PJVD000270PJVD000271PJVD000272PJVD000273PJVD000274PJVD000275PJVD000276PJVD000277PJVD000278PJVD000279PJVD000280PJVD000281PJVD000282PJVD000283PJVD000284PJVD000285PJVD000286PJVD000287PJVD000288PJVD000289PJVD000290PJVD000291PJVD000292PJVD000293PJVD000294PJVD000295PJVD000297PJVD000298PJVD000299PJVD000300PJVD000301P
- Serial Numbers
- Amount recalled
- 6713 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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