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.
FDA Recall Z-2125-2016 · Posted 2016-07-05
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Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure
Recall StatusTerminated
Product CodeNVZ
Date Initiated2016-05-26
Date Terminated2016-10-27
Product Quantity262
Reason for Recall
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.
Firm Action
Medtronic sent an Urgent Field Safety Notice dated May 2016 to all affected customers. The letter described the issue and the product involved in the recall. The letter also included the "Customer Actions" for consignees to follow. Requested consignees to complete and return the Customer Confirmation Certificate to or via fax to <651-367-0612> to the attention of .
For assistance, please contact your local Medtronic Representative or Medtronic.
For questions regarding this recall call 763-514-4000.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution to Austria, Belgium, China , Czech Republic , Denmark , Finland , France, Germany, Hong Kong, India , Ireland , Israel, Italy , Malaysia, Netherlands, Norway, Poland, Portugal , Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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