Reported Jan 31, 2018 · Terminated
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The…
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 Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician.
- Lot codes and dates
- Model (UPN/GTIN)
122 of 122 codes
24950 (006431692922840064316929234500643169292260006431692925290064316929220800643169292192006431692922220064316929223900643169292321006431692922150064316929224600643169409132006431692922530064316929227700643169292291006431692923070064316929231400643169292338)24950D (643169467163006431694414840064316944110100643169367173006431693672270064316936715900643169409156006431693672960064316936730200643169367258006431693671800064316936716600643169367210006431693672890064316940914900643169367197006431693671420064316936724100643169367203)24950D1 (00643169486744)24950E (00643169493667006431694936810064316949369800643169493674006431694519880064316945201500643169452107006431694520390064316945212100643169452008006431694521450064316945204600643169452022006431694520530064316945213800643169452060006431694519950064316945211400643169452152006431694520770064316945208400643169452091)
- Model (UPN/GTIN)
- 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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