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U.S. Department of Health and Human Services

Medical Device Recalls

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51 to 60 of 61 Results
PMA Number: P910023
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Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/5... 2 06/29/2018 St Jude Medical Inc.
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100,... 2 06/12/2018 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.
Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD141... 2 05/10/2016 St Jude Medical Inc.
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD... 2 02/24/2020 St Jude Medical, Cardiac Rhythm Management Division
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Mo... 2 01/13/2020 St Jude Medical, Cardiac Rhythm Management Division
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q 2 04/21/2022 St. Jude Medical, Cardiac Rhythm Management Division
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q 2 04/21/2022 St. Jude Medical, Cardiac Rhythm Management Division
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