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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 45 Results
PMA Number: P030054
 
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Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40... 1 10/10/2017 St Jude Medical Inc.
Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assur... 1 10/21/2016 St Jude Medical Inc.
Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF C... 2 09/19/2023 Abbott Medical
Merlin PCS 3650 programmer Model 3330 software 2 04/21/2022 St. Jude Medical, Cardiac Rhythm Management Division
Merlin 2 PCS MER3700 programmer Model MER3400 software 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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407,... 2 06/29/2018 St Jude Medical Inc.
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334,... 2 06/29/2018 St Jude Medical Inc.
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029... 2 06/29/2018 St Jude Medical Inc.
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336,... 2 06/29/2018 St Jude Medical Inc.
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