St Jude Medical recalls
St Jude Medical appears in 73 official U.S. recall notices indexed by RecallRadar, most recently on 2025-04-02.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM…
FDA Device · Class II · 2025-04-02 · St Jude Medical - Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model…
FDA Device · Class II · 2025-01-29 · St Jude Medical - CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Networ…
FDA Device · Class II · 2025-01-29 · St Jude Medical - CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Netwo…
FDA Device · Class II · 2025-01-29 · St Jude Medical - St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
FDA Device · Class II · 2024-07-24 · St Jude Medical - CardioMEMS Patient Electronic System (PES), Model Number CM1100
FDA Device · Class II · 2023-11-15 · St Jude Medical - CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodyn…
FDA Device · Class II · 2023-03-15 · St Jude Medical - CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynami…
FDA Device · Class II · 2023-03-15 · St Jude Medical - CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodyn…
FDA Device · Class II · 2023-03-15 · St Jude Medical - CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodyn…
FDA Device · Class II · 2023-03-15 · St Jude Medical - CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynami…
FDA Device · Class II · 2023-03-15 · St Jude Medical - CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemody…
FDA Device · Class II · 2023-03-15 · St Jude Medical - CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynami…
FDA Device · Class II · 2023-03-15 · St Jude Medical - ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
FDA Device · Class I · 2019-08-14 · St Jude Medical - ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
FDA Device · Class I · 2019-08-14 · St Jude Medical - ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
FDA Device · Class I · 2019-08-14 · St Jude Medical - ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
FDA Device · Class I · 2019-08-14 · St Jude Medical - ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
FDA Device · Class I · 2019-08-14 · St Jude Medical - ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
FDA Device · Class I · 2019-08-14 · St Jude Medical - St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano,…
FDA Device · Class II · 2018-12-19 · St Jude Medical - Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted de…
FDA Device · Class II · 2018-07-11 · St Jude Medical - St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and…
FDA Device · Class II · 2018-07-11 · St Jude Medical - Merlin PCS programmer (Model # 3650), Software (Model # 3330)
FDA Device · Class II · 2018-07-04 · St Jude Medical - Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195
FDA Device · Class II · 2018-07-04 · St Jude Medical - Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407
FDA Device · Class II · 2018-07-04 · St Jude Medical - Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623
FDA Device · Class II · 2018-07-04 · St Jude Medical - Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944
FDA Device · Class II · 2018-07-04 · St Jude Medical - Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904
FDA Device · Class II · 2018-07-04 · St Jude Medical - Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095,…
FDA Device · Class II · 2018-07-04 · St Jude Medical - Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115
FDA Device · Class II · 2018-07-04 · St Jude Medical - Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846
FDA Device · Class II · 2018-07-04 · St Jude Medical - Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177
FDA Device · Class II · 2018-07-04 · St Jude Medical - Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407
FDA Device · Class II · 2018-07-04 · St Jude Medical - Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981
FDA Device · Class II · 2018-07-04 · St Jude Medical - Proclaim DRG Implantable Pulse Generator, Model Number 3664
FDA Device · Class II · 2018-04-04 · St Jude Medical - PM 1250 and PM 2250 ZENEX
FDA Device · Class II · 2017-10-25 · St Jude Medical - Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
FDA Device · Class II · 2017-10-25 · St Jude Medical - PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the b…
FDA Device · Class II · 2017-10-25 · St Jude Medical - Anthem Model Numbers: PM3210, PM3212
FDA Device · Class II · 2017-10-25 · St Jude Medical - Proclaim DRG Implantable Pulse Generator Model 3664
FDA Device · Class II · 2017-10-25 · St Jude Medical - Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
FDA Device · Class II · 2017-10-25 · St Jude Medical - PM1214 NUANCE SR RF
FDA Device · Class II · 2017-10-25 · St Jude Medical - Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indi…
FDA Device · Class II · 2017-10-25 · St Jude Medical - Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable…
FDA Device · Class II · 2017-10-25 · St Jude Medical - PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be p…
FDA Device · Class II · 2017-10-25 · St Jude Medical - Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitt…
FDA Device · Class II · 2017-10-25 · St Jude Medical - PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be…
FDA Device · Class II · 2017-10-25 · St Jude Medical - Assurity Model Numbers: PM1240, PM2240
FDA Device · Class II · 2017-10-25 · St Jude Medical - Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q
FDA Device · Class I · 2017-10-18 · St Jude Medical - Unify, Model Numbers: CD3231-40 and CD3231-40Q
FDA Device · Class I · 2017-10-18 · St Jude Medical