Class 2 Device Recall Medtronic, MyCareLink Patient Monitor

• Date Initiated by Firm: May 26, 2016
• Date Posted: July 05, 2016
• Recall Status: Terminated on October 27, 2016
• Recall Number: Z-2125-2016
• Recall Event ID: 74344
• PMA Number: P890003S269
• Product Classification: Pulse generator, permanent, implantable - Product Code NVZ
• 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.
• Code Information: 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 YDM368670A YDM020290A YDM157438A YDM266778A YDM297528A YDM336461A YDM369861A YDM020298A YDM157859A YDM267760A YDM298219A YDM336479A YDM369882A YDM022307A YDM167864A YDM267780A YDM302707A YDM336759A YDM369923A YDM023936A YDM179487A YDM268447A YDM303547A YDM336846A YDM369928A YDM032480A YDM182698A YDM272202A YDM303555A YDM337081A YDM369939A YDM033976A YDM183406A YDM272660A YDM304176A YDM337083A YDM370040A YDM037712A YDM184560A YDM274102A YDM304209A YDM337439A YDM371430A YDM037957A YDM184823A YDM274701A YDM315137A YDM337452A YDM371639A YDM042190A YDM186805A YDM278813A YDM315420A YDM337535A YDM371740A YDM042952A YDM194474A YDM279279A YDM315576A YDM337635A YDM371746A YDM043309A YDM194904A YDM279482A YDM315625A YDM337947A YDM371866A YDM050840A YDM195374A YDM279555A YDM315642A YDM337949A YDM371913A YDM051330A YDM196814A YDM280192A YDM315743A YDM337950A YDM371917A YDM051664A YDM199276A YDM280262A YDM315745A YDM337982A YDM371936A YDM052090A YDM199759A YDM280387A YDM315933A YDM337994A YDM371980A YDM052600A YDM200646A YDM280758A YDM315951A YDM338008A YDM372020A YDM054481A YDM200652A YDM280769A YDM316047A YDM338024A YDM372047A YDM071665A YDM208697A YDM280805A YDM316064A YDM338098A YDM372049A YDM071666A YDM209303A YDM281138A YDM316068A YDM338100A YDM372055A YDM078576A YDM210153A YDM281848A YDM316071A YDM338144A YDM372056A YDM078845A YDM211969A YDM284759A YDM316097A YDM338334A YDM372062A YDM081835A YDM213914A YDM284783A YDM316110A YDM338356A YDM372071A YDM083551A YDM217670A YDM285023A YDM316160A YDM338441A YDM372077A YDM084623A YDM221316A YDM285199A YDM316368A YDM338444A YDM404227A YDM085232A YDM221351A YDM285252A YDM316397A YDM338452A YDM086050A YDM230247A YDM285714A YDM316469A YDM338460A
• Recalling Firm/ Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure; 8200 Coral Sea St NE; Mounds View MN 55112-4391
• For Additional Information Contact: local Medtronic Representative ; 763-514-4000
• Manufacturer 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: 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NVZ and Original Applicant = Medtronic, Inc.