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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, C...
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2
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09/03/2014
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St Jude Medical Cardiac Rhythm Management Division
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Ellipse, Sterile EO, Model #/ Part #:
CD1275-36/100116115;
CD1275-36Q/100116116;
CD1277-36/1000...
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2
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06/29/2018
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St Jude Medical Inc.
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Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD...
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2
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02/24/2020
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St Jude Medical, Cardiac Rhythm Management Division
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Fortify Assura, Sterile EO, Model #/ Part #:
CD1257-40/100042322, 100059623;
CD1257-40Q/10004234...
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2
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06/29/2018
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St Jude Medical Inc.
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Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD...
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1
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10/10/2017
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St Jude Medical Inc.
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Fortify VR, Model No. CD1231-40, CD1231-40Q.
Fortify ST VR, Model No. CD1241-40, CD1241-40Q.
Forti...
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1
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10/21/2016
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St Jude Medical Inc.
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Fortify, Sterile EO, Model #/ Part #:
CD1231-40/100029238,100030095, 100041981;
CD1231-40Q/10002...
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2
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06/29/2018
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St Jude Medical Inc.
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Gallant DR Implantable Cardioverter Defibrillator
REF # CDDRA500Q
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2
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04/21/2022
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St. Jude Medical, Cardiac Rhythm Management Division
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Gallant HF Implantable Cardioverter Defibrillator
REF# CDHFA500Q
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2
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04/21/2022
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St. Jude Medical, Cardiac Rhythm Management Division
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Gallant VR Implantable Cardioverter Defibrillator
REF # CDVRA500Q
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2
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04/21/2022
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St. Jude Medical, Cardiac Rhythm Management Division
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