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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 61 Results
PMA Number: P910023
 
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ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) 1 08/02/2019 St Jude Medical Inc.
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585 1 08/02/2019 St Jude Medical Inc.
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) 1 08/02/2019 St Jude Medical Inc.
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) 1 08/02/2019 St Jude Medical Inc.
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615 1 08/02/2019 St Jude Medical Inc.
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738 1 08/02/2019 St Jude Medical Inc.
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD... 1 10/10/2017 St Jude Medical Inc.
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No.... 1 10/21/2016 St Jude Medical Inc.
Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Forti... 1 10/21/2016 St Jude Medical Inc.
Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Car... 2 09/19/2023 Abbott Medical
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