Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring

FDA device recall Z-2125-2016 · posted 2016-07-05 · Terminated

Recall details

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure

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.

Action taken

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

Status

Terminated

Product code

NVZ

Quantity affected

262

Distribution

Worldwide Distribution to Austria, Belgium, China , Czech Republic , Denmark , Finland , France, Germany, Hong Kong, India , Ireland , Israel, Italy , Malaysia, Netherlands, Norway, Poland, Portugal ,

Date initiated

2016-05-26

Date posted

2016-07-05

Date terminated

2016-10-27

Location

Mounds View, MN