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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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Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Car... 2 09/19/2023 Abbott Medical
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q 2 04/21/2022 St. Jude Medical, Cardiac Rhythm Management Division
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q 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
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System ... 2 04/10/2020 Abbott
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
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.
Merlin PCS programmer (Model # 3650), Software (Model # 3330) 2 06/29/2018 St Jude Medical Inc.
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