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U.S. Department of Health and Human Services

Medical Device Recalls

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11 to 20 of 61 Results
PMA Number: P910023
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ELLIPSE DR, REF: CD2377-36QC 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 DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585 1 08/02/2019 St Jude Medical Inc.
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD32... 2 06/29/2018 St Jude Medical Inc.
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/10004234... 2 06/29/2018 St Jude Medical Inc.
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/10002... 2 06/29/2018 St Jude Medical Inc.
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/1000... 2 06/29/2018 St Jude Medical Inc.
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 PCS programmer (Model # 3650), Software (Model # 3330) 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.
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