Reported Jan 31, 2018 · Terminated
MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device.…
Medtronic Inc., Cardiac Rhythm and Heart Failure
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 · 8200 Coral Sea St NE · Mounds View, MN · 55112-4391
Is this the product you have?
- MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device
- Lot codes and dates
Model 25000UPN/GTIN 00643169527546006431695697440064316966633700643169697843¿0064316986287600643169697850006431697422460064316986288300643169666375006431696663820064316966634400643169666351006431696663680064316966632000643169590397006431695275840064316952759100643169527553006431695275600064316952757700643169947108
- Amount recalled
- 1,519,984 enrollments total
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
Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.
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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