PlainRecalls

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

131 recalls on record · Latest: Jun 28, 2023

FDA Devices Moderate Jul 15, 2020

Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04

FDA Devices Moderate Jul 15, 2020

CareLink SmartSync Device Manager, Model Number 24970A

FDA Devices Moderate Jul 15, 2020

Azure S DR MRI, Model Number W3DR01

FDA Devices Moderate Jul 15, 2020

Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01

FDA Devices Moderate Jul 15, 2020

Azure S SR MRI, Model Number W3SR01

FDA Devices Moderate Jul 15, 2020

Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01

FDA Devices Moderate Jul 15, 2020

Patient Connector, Model Number 24967

FDA Devices Moderate Jul 15, 2020

Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05

FDA Devices Moderate Mar 25, 2020

Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

FDA Devices Moderate Nov 6, 2019

Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer

FDA Devices Moderate Nov 6, 2019

Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager

FDA Devices Moderate Sep 18, 2019

Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.

FDA Devices Low Apr 3, 2019

Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be us…

FDA Devices Moderate Feb 27, 2019

Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer

FDA Devices Critical Feb 20, 2019

Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVD…

FDA Devices Critical Feb 20, 2019

Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Mode…

FDA Devices Critical Feb 20, 2019

vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model …

FDA Devices Moderate Feb 13, 2019

MEDTRONIC CARELINK 2090 programmer

FDA Devices Moderate Nov 14, 2018

Medtronic CareLink Encore 29901 Programmer

FDA Devices Moderate Jul 18, 2018

Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (…

FDA Devices Moderate Jul 18, 2018

Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization ther…

FDA Devices Moderate Jul 18, 2018

Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization ther…

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Produ…

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular a…

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Prod…

FDA Devices Moderate Jul 18, 2018

Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Produ…

FDA Devices Critical Feb 28, 2018

Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Ever…

FDA Devices Critical Feb 28, 2018

Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD …

FDA Devices Critical Feb 28, 2018

Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF…

FDA Devices Critical Feb 28, 2018

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. …

FDA Devices Critical Feb 28, 2018

Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); …