Reported Nov 6, 2019 · Ongoing
Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
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 AppsCareLink SmartSync Device Manager
- Lot codes and dates
- Serial NumbersSPM
2,715 of 2,715 codes
SPM001018ASPM001019ASPM001020ASPM001021ASPM001022ASPM001023ASPM001024ASPM001025ASPM001026ASPM001027ASPM001028ASPM001029ASPM001030ASPM001031ASPM001032ASPM001033ASPM001034ASPM001035ASPM001036ASPM001037ASPM001038ASPM001039ASPM001040ASPM001041ASPM001042ASPM001043ASPM001044ASPM001045ASPM001046ASPM001047ASPM001078ASPM001079ASPM001080ASPM001081ASPM001082ASPM001083ASPM001084ASPM001085ASPM001086ASPM001087ASPM001092ASPM001093ASPM001094ASPM001096ASPM001097ASPM001098ASPM001100ASPM001101ASPM001102ASPM001103ASPM001105ASPM001106ASPM001107ASPM001108ASPM001109ASPM001110ASPM001111ASPM001112ASPM001113ASPM001114A
- Serial Numbers
- Amount recalled
- 874 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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