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St. Jude Medical

44 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM recall (Z-1427-2025)St. Jude Medical2025-03-21
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which recall (Z-0987-2025)St. Jude Medical2025-01-17
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics Syste recall (Z-0988-2025)St. Jude Medical2025-01-17
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics Syst recall (Z-0989-2025)St. Jude Medical2025-01-17
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 recall (Z-2348-2024)St. Jude Medical2024-07-12
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measu recall (Z-0218-2024)St. Jude Medical2023-11-03
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF recall (Z-1223-2023)St. Jude Medical2023-03-06
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF recall (Z-1224-2023)St. Jude Medical2023-03-06
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF recall (Z-1225-2023)St. Jude Medical2023-03-06
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS recall (Z-1218-2023)St. Jude Medical2023-03-03
CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS recall (Z-1219-2023)St. Jude Medical2023-03-03
CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS recall (Z-1220-2023)St. Jude Medical2023-03-03
CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEM recall (Z-1221-2023)St. Jude Medical2023-03-03
TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation o recall (Z-1284-2015)St Jude Medical2015-03-17
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353 recall (Z-0177-2015)St Jude Medical2014-11-06
St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The recall (Z-0108-2015)St Jude Medical2014-10-22
Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile recall (Z-0187-2014)St. Jude Medical2013-11-08
US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation recall (Z-0174-2014)St. Jude Medical2013-11-06
Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic recall (Z-1836-2013)St. Jude Medical2013-07-31
Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable C recall (Z-1785-2013)St. Jude Medical2013-07-22
Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is i recall (Z-1738-2013)St. Jude Medical2013-07-16
Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the ma recall (Z-1739-2013)St. Jude Medical2013-07-16
7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83724, Description: recall (Z-3255-2011)St Jude Medical2011-09-16
7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83725, Description: recall (Z-3256-2011)St Jude Medical2011-09-16
7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726, Description: recall (Z-3257-2011)St Jude Medical2011-09-16
Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, S recall (Z-2955-2011)St. Jude Medical2011-08-05
1500T12 Cool Path Ablation System - Generator The generator is a microprocessor-controlled recall (Z-2630-2011)St Jude Medical2011-06-23
1500T14 Cardiac Ablation System - Generator The 1500Tl4 Cardiac Ablation System operates i recall (Z-2631-2011)St Jude Medical2011-06-23
1500T14 Cardiac Ablation System - Remote Control The 1500Tl4 Remote Control can control an recall (Z-2632-2011)St Jude Medical2011-06-23
St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Ma recall (Z-2228-2009)St. Jude Medical2009-09-18
St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Ma recall (Z-2229-2009)St. Jude Medical2009-09-18
SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewi recall (Z-1713-2009)St. Jude Medical2009-08-17
SJM Peel Away Introducer, REF 405153, Lot 2694252, Length 14 cm, 7F (2.33 mm), Max Guidewi recall (Z-1714-2009)St. Jude Medical2009-08-17
EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; EP Me recall (Z-1422-2009)St. Jude Medical2009-06-12
NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; USA EPMedSys recall (Z-1156-2009)St. Jude Medical2009-04-10
Photo DR, Model V-230HV Implantable Cardioverter Defibrillator recall (Z-0146-06)St Jude Medical2005-11-16
Photo Micro VR/DR Models V-194 recall (Z-0147-06)St Jude Medical2005-11-16
Photo Micro VR/DR Models V-232 recall (Z-0148-06)St Jude Medical2005-11-16
Atlas VR, Models V-199 recall (Z-0149-06)St Jude Medical2005-11-16
Atlas DR, Models V-240 recall (Z-0150-06)St Jude Medical2005-11-16
Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF recall (Z-1017-05)St Jude Medical2005-07-19
Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Model recall (Z-0709-05)St Jude Medical2005-04-13
Pulse Generator recall (Z-0052-04)St Jude Medical2003-10-24
Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Te recall (Z-0341-03)St Jude Medical2002-12-18

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Every clearance here is in the API, with alerts when new ones post.