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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 9 of 9 Results
PMA Number: P010015
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Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05 2 07/10/2020 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06 2 07/10/2020 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04 2 07/10/2020 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pul... 2 07/10/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pul... 2 07/10/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse ge... 2 07/10/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse ge... 2 07/10/2018 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker. 2 11/27/2015 Medtronic Inc.
Medtronic, Consulta® CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra® CRT-P, Model C... 2 06/27/2013 Medtronic Inc. Cardiac Rhythm Disease Management
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