Recall Z-2125-2016
Medtronic Inc., Cardiac Rhythm and Heart Failure · initiated May 26, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Serial #'s: YDM001132A YDM091046A YDM230250A YDM287007A YDM316478A YDM338461A YDM001745A YDM092101A YDM230251A YDM287161A YDM319952A YDM338462A YDM002664A YDM096286A YDM230252A YDM287223A YDM320649A YDM338463A YDM002701A YDM100162A YDM230254A YDM287345A YDM320877A YDM338577A YDM003337A YDM102883A YDM230265A YDM287370A YDM321013A YDM339781A YDM004445A YDM102905A YDM231186A YDM287388A YDM321225A YDM339914A YDM004921A YDM110112A YDM231295A YDM287416A YDM334335A YDM340510A YDM005795A YDM127412A YDM231296A YDM287421A YDM335349A YDM340704A YDM010849A YDM127843A YDM234714A YDM287435A YDM335397A YDM358237A YDM010853A YDM128264A YDM240991A YDM289828A YDM335518A YDM359331A YDM011147A YDM141892A YDM241982A YDM289829A YDM335520A YDM359860A YDM011149A YDM144415A YDM242216A YDM291918A YDM335555A YDM362795A YDM011272A YDM150513A YDM242217A YDM291922A YDM336083A YDM363407A YDM012137A YDM150765A YDM252868A YDM291931A YDM336111A YDM366123A YDM013030A YDM150783A YDM253726A YDM292587A YDM336391A YDM366134A YDM015178A YDM150795A YDM261210A YDM292592A YDM336411A YDM366212A YDM015183A YDM150796A YDM265729A YDM292634A YDM336426A YDM367410A YDM015353A YDM150864A YDM266233A YDM295750A YDM336434A…
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.
FDA-determined cause: Software design
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.
Details
- Recall number
- Z-2125-2016
- Initiated
- May 26, 2016
- Posted by FDA
- July 5, 2016
- Terminated
- October 27, 2016
- Product code
- NVZ – Pulse Generator, Permanent, Implantable
- Quantity
- 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 , Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN