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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 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 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 S SR MRI, Model Number W3SR01	2	07/10/2020	FEI # 2182208 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Azure S DR MRI, Model Number W3DR01	2	07/10/2020	FEI # 2182208 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemak...	1	02/14/2019	FEI # 2182208 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED...	1	02/14/2019	FEI # 2182208 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pace...	1	02/14/2019	FEI # 2182208 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED0...	1	02/14/2019	FEI # 2182208 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD...	1	02/14/2019	FEI # 2182208 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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