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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 S SR MRI, Model Number W3SR01	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)
Kappa Model 701 Implantable Pulse Generators (IPGs) are pacemaker devices that provide therapies for...	2	07/20/2004	FEI # 2182208 Medtronic Inc. Cardiac Rhythm Managment
Kappa Model 901 Implantable Pulse Generators (IPGs) are pacemaker devices that provide therapies for...	2	07/20/2004	FEI # 2182208 Medtronic Inc. Cardiac Rhythm Managment
Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The ...	2	04/26/2010	FEI # 2182208 Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Pacemaker, model...	1	06/11/2009	FEI # 2182208 Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Rate Responsive ...	1	06/11/2009	FEI # 2182208 Medtronic Inc. Cardiac Rhythm Disease Managment

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