Reported Jul 13, 2016 · Terminated
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote…
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?
- Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
- Lot codes and dates
- Serial #'s:
262 of 262 codes
YDM001132AYDM091046AYDM230250AYDM287007AYDM316478AYDM338461AYDM001745AYDM092101AYDM230251AYDM287161AYDM319952AYDM338462AYDM002664AYDM096286AYDM230252AYDM287223AYDM320649AYDM338463AYDM002701AYDM100162AYDM230254AYDM287345AYDM320877AYDM338577AYDM003337AYDM102883AYDM230265AYDM287370AYDM321013AYDM339781AYDM004445AYDM102905AYDM231186AYDM287388AYDM321225AYDM339914AYDM004921AYDM110112AYDM231295AYDM287416AYDM334335AYDM340510AYDM005795AYDM127412AYDM231296AYDM287421AYDM335349AYDM340704AYDM010849AYDM127843AYDM234714AYDM287435AYDM335397AYDM358237AYDM010853AYDM128264AYDM240991AYDM289828AYDM335518AYDM359331A
- Serial #'s:
- Amount recalled
- 262
Why it was recalled
Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue with the software that prevents implanted device data from being available to clinicians on the CareLink Network. While the transmission appears successful to the patient, the transmitted data, including CareAlerts, are not visible to the clinic.
This product could cause temporary or reversible health problems — stop using it.
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