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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 30 Results
PMA Number: P980035
 
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Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01 2 07/10/2020 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01 2 07/10/2020 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Azure S SR MRI, Model Number W3SR01 2 07/10/2020 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Azure S DR MRI, Model Number W3DR01 2 07/10/2020 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 The devices are implantable pulse... 2 04/29/2011 Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The ... 2 04/26/2010 Medtronic Inc. Cardiac Rhythm Disease Managment
Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303 2 02/18/2006 Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Single Chamber Rate Responsive Pacemaker, models SSR203, S... 2 02/18/2006 Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS30... 2 02/18/2006 Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacin... 2 02/18/2006 Medtronic Inc. Cardiac Rhythm Managment
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