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Medical Device Recalls

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1 to 10 of 31 Results
PMA Number: P980035

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Product Description	Recall Class	FDA Recall Posting Date	Recalling Firm
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Azure S DR MRI SureScan, Product number W3DR01	2	06/06/2025	FEI # 2182208 Medtronic, Inc.
Azure S DR MRI, Model Number W3DR01	2	07/10/2020	FEI # 2182208 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01	2	07/10/2020	FEI # 2182208 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01	2	07/10/2020	FEI # 2182208 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Azure S SR MRI, Model Number W3SR01	2	07/10/2020	FEI # 2182208 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	FEI # 2182208 Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The ...	2	04/26/2010	FEI # 2182208 Medtronic Inc. Cardiac Rhythm Disease Managment
Sigma implantable pulse generators (IPGs) Single Chamber Rate Responsive Pacemaker, models SSR203, S...	2	02/18/2006	FEI # 2182208 Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS30...	2	02/18/2006	FEI # 2182208 Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacin...	2	02/18/2006	FEI # 2182208 Medtronic Inc. Cardiac Rhythm Managment

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