Home / Brands / Medtronic Inc., Cardiac Rhythm and Heart Failure
Medtronic Inc., Cardiac Rhythm and Heart Failure Recalls
9 recalls on record · May 11, 2016 to January 31, 2018 · Medical Devices
Recalls by year
16
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 31, 2018Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure recalls MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device.
Hazard: Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.
January 31, 2018Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure recalls MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The
Hazard: Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.
May 31, 2017Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure recalls Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
Hazard: An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.
January 18, 2017Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure recalls Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CR
Hazard: During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active.
August 31, 2016Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure recalls Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1,
Hazard: 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
August 31, 2016Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure recalls Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTB
Hazard: 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
July 20, 2016Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure recalls Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack
Hazard: This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting a patients lead to a possible hazardous voltage.
July 13, 2016Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure recalls Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitorin
Hazard: 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.
May 11, 2016Medical DevicesFDA
Medtronic Inc., Cardiac Rhythm and Heart Failure recalls Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLin
Hazard: A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the country analog modem dial-up configuration table used to dial into the CareLink Network. This incorrect data resulted in the removal of the 0 prefix necessary for select countries as well as an incorrect alignment of phone numbers for other select cou