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Medtronic, Inc.

227 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablat recall (Z-1948-2026)Medtronic, Inc.2026-04-24
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080 recall (Z-1098-2026)Medtronic Inc2026-01-15
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter recall (Z-0726-2026)Medtronic, Inc.2025-11-28
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following soft recall (Z-2168-2025)Medtronic, Inc.2025-07-23
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following softwa recall (Z-2169-2025)Medtronic, Inc.2025-07-23
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 wit recall (Z-2127-2025)Medtronic, Inc.2025-07-17
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 249 recall (Z-2128-2025)Medtronic, Inc.2025-07-17
Azure S DR MRI SureScan, Product number W3DR01 recall (Z-1924-2025)Medtronic, Inc.2025-06-06
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: recall (Z-3152-2024)Medtronic Inc.2024-09-13
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibril recall (Z-2190-2024)Medtronic Inc.2024-06-26
COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrill recall (Z-2191-2024)Medtronic Inc.2024-06-26
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrill recall (Z-2192-2024)Medtronic Inc.2024-06-26
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defib recall (Z-2193-2024)Medtronic Inc.2024-06-26
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defib recall (Z-2194-2024)Medtronic Inc.2024-06-26
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrill recall (Z-2195-2024)Medtronic Inc.2024-06-26
EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator recall (Z-2196-2024)Medtronic Inc.2024-06-26
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator recall (Z-2197-2024)Medtronic Inc.2024-06-26
EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator recall (Z-2198-2024)Medtronic Inc.2024-06-26
EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator recall (Z-2199-2024)Medtronic Inc.2024-06-26
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator recall (Z-2200-2024)Medtronic Inc.2024-06-26
MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator recall (Z-2201-2024)Medtronic Inc.2024-06-26
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator recall (Z-2202-2024)Medtronic Inc.2024-06-26
PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator recall (Z-2203-2024)Medtronic Inc.2024-06-26
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator recall (Z-2204-2024)Medtronic Inc.2024-06-26
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator recall (Z-2205-2024)Medtronic Inc.2024-06-26
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator recall (Z-2206-2024)Medtronic Inc.2024-06-26
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator recall (Z-2207-2024)Medtronic Inc.2024-06-26
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator recall (Z-2208-2024)Medtronic Inc.2024-06-26
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator recall (Z-2209-2024)Medtronic Inc.2024-06-26
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator recall (Z-2210-2024)Medtronic Inc.2024-06-26
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator recall (Z-2211-2024)Medtronic Inc.2024-06-26
Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD X recall (Z-2212-2024)Medtronic Inc.2024-06-26
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090 recall (Z-1317-2024)Medtronic Inc.2024-03-19
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 recall (Z-0779-2024)Medtronic Inc.2024-01-22
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Steril recall (Z-0623-2024)Medtronic Inc.2024-01-02
Medtronic SynchroMed, Model A10 recall (Z-0522-2024)Medtronic Inc.2023-12-09
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor recall (Z-0421-2024)Medtronic Inc.2023-12-01
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6 recall (Z-0320-2024)Medtronic Inc2023-11-17
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6 recall (Z-0321-2024)Medtronic Inc2023-11-17
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5 recall (Z-0322-2024)Medtronic Inc2023-11-17
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) recall (Z-0927-2022)Medtronic Inc2022-04-18
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 007630 recall (Z-2206-2020)Medtronic Inc.2020-06-03
Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, M recall (Z-0955-2020)Medtronic Inc.2020-02-07
Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742 recall (Z-0956-2020)Medtronic Inc.2020-02-07
Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MM recall (Z-0957-2020)Medtronic Inc.2020-02-07
Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-151 recall (Z-0958-2020)Medtronic Inc.2020-02-07
Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, recall (Z-0177-2020)Medtronic Inc.2019-11-04
Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use wi recall (Z-0178-2020)Medtronic Inc.2019-11-04
Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctionin recall (Z-1880-2019)Medtronic Inc2019-06-26
Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctionin recall (Z-1881-2019)Medtronic Inc2019-06-26
Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfun recall (Z-1882-2019)Medtronic Inc2019-06-26
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunc recall (Z-1883-2019)Medtronic Inc2019-06-26
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunc recall (Z-1884-2019)Medtronic Inc2019-06-26
Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754 recall (Z-2377-2018)Medtronic Inc.2018-07-05
6F Taiga Guiding Catheter recall (Z-1207-2018)Medtronic Inc2018-03-29
MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affect recall (Z-1890-2017)Medtronic Inc.2017-04-28
ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA recall (Z-0892-2017)Medtronic Inc2016-12-22
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Ve recall (Z-0826-2017)Medtronic Inc2016-12-20
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker. recall (Z-0342-2016)Medtronic Inc.2015-11-27
Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Mod recall (Z-0200-2016)Medtronic Inc.2015-11-02
Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate balloon recall (Z-2271-2010)Medtronic, Inc.2010-08-25
Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon recall (Z-2272-2010)Medtronic, Inc.2010-08-25
Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to inflate/deflate balloon recall (Z-2273-2010)Medtronic, Inc.2010-08-25
Medtronic HMS PLUS, Hemostasis Management System, Model 30514. It is a microprocessor base recall (Z-1070-2010)Medtronic Inc2010-03-11
IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtr recall (Z-0868-2010)Medtronic Inc2010-02-26
ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS), Manufacturer: Medtronic, Inc., Minneapolis, recall (Z-0869-2010)Medtronic Inc2010-02-26
Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C recall (Z-1225-2009)Medtronic Inc2009-05-29
Hancock II Bioprostheses with Cinch, Heart Valve, Model # T505 & T510; Catalog #s T505C250 recall (Z-1226-2009)Medtronic Inc2009-05-29
Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F recall (Z-1173-2009)Medtronic Inc2009-04-14
Medtronic Surgical Membrane Oxygenator. Mis-printed Label: Medtronic 1-4500-2A, Recommende recall (Z-0975-2009)Medtronic Inc2009-02-09
5 F BardSelect 11 cm Percutaneous Catheter Introducer Set Ref: 050A11 Percutaneous cathete recall (Z-0441-2009)Medtronic, Inc.2008-12-02
6 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 060A11 Percutaneous catheter recall (Z-0442-2009)Medtronic, Inc.2008-12-02
7 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 070A11 Percutaneous catheter recall (Z-0443-2009)Medtronic, Inc.2008-12-02
Medtronic Input TS 7F 11 cm Ref: 071102A Percutaneous catheter introducer sets, including recall (Z-0444-2009)Medtronic, Inc.2008-12-02
Medtronic Export XT Aspiration Catheter, 6F (US) Medtronic Export XT Aspiration Catheter, recall (Z-0063-2008)Medtronic, Inc.2007-10-31
CATHETER LA5IMAA 5F 110CM Coronary Guiding catheter designed to provide a pathway through recall (Z-0930-06)Medtronic, Inc.2006-06-01
CATH.GUIDE 5F JL 4.0 110CM CATHETER LA5JL40A LA 5F 110CM JL40 Coronary Guiding catheter de recall (Z-0931-06)Medtronic, Inc.2006-06-01
CATH.GUIDE 5F JR 4.0 110CM CATHETER LA5JR40A LA 5F 110CM JR4.0 Coronary Guiding catheter d recall (Z-0932-06)Medtronic, Inc.2006-06-01
CATH GUIDE 5F SR3.0 LAUNCHER CATHETER LA5SR30 LA 5F 100CM SR30 Coronary Guiding catheter d recall (Z-0933-06)Medtronic, Inc.2006-06-01
CATH GUIDE 5F SR3.5 LAUNCHER CATHETER LA5SR35 LA 5F 100CM SR35 Coronary Guiding catheter d recall (Z-0934-06)Medtronic, Inc.2006-06-01
CATH GUIDE 5F SR4.0 LAUNCHER CATHETER LA5SR40 LA 5F 100CM SR40 Coronary Guiding catheter d recall (Z-0935-06)Medtronic, Inc.2006-06-01
CATH.GUIDE 5F SR 5.0 110CM CATHETER LA5SR50A LA 5F 110CM SR5 Coronary Guiding catheter des recall (Z-0936-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F 3DRC LAUNCHER CATHETER LA63DRC LA 6F 100CM 3DRC Coronary Guiding catheter d recall (Z-0937-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F 3DRC W/SH LAUNC CATHETER LA63DRCSH LA 6F 100CM 3DRC Coronary Guiding cathet recall (Z-0938-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F AL 1.0 110CM LA CATHETER LA6AL10A LA 6F 110CM AL10 Coronary Guiding cathete recall (Z-0939-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F AL 2.0 110CM LA CATHETER LA6AL20A LA 6F 110CM AL20 Coronary Guiding cathete recall (Z-0940-06)Medtronic, Inc.2006-06-01
CATH GUIDE 6F LAUNCHER AL 3.0 CATHETER LA6AL30A LA 6F 110CM AL30 Coronary Guiding catheter recall (Z-0941-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F EBU3.5 110CM LA CATHETER LA6EBU35A LA 6F 110CM EB35 Coronary Guiding cathet recall (Z-0942-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F EBU4.0 110CM LA CATHETER LA6EBU40A LA 6F 110CM EB40 Coronary Guiding cathet recall (Z-0943-06)Medtronic, Inc.2006-06-01
CATH GUIDE 6F LAUNCHER EBU 4.5 CATHETER LA6EBU45A LA 6F 110CM EB45 Coronary Guiding cathet recall (Z-0944-06)Medtronic, Inc.2006-06-01
CATHETER LA6HSIA 6F 110CM HSI Coronary Guiding catheter designed to provide a pathway thro recall (Z-0945-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F JL3.5 110CM LAU CATHETER LA6JL35A LA 6F 110CM JL35 Coronary Guiding cathete recall (Z-0946-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F JL4.0 5 PACK LA Coronary Guiding catheter designed to provide a pathway thr recall (Z-0947-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F JL4.0 110CM LAU CATHETER LA6JL40A LA 6F 110CM JL40 Coronary Guiding cathete recall (Z-0948-06)Medtronic, Inc.2006-06-01
CATH.GUIDE 6F JL 4.0 SH 110CM CATHETER LA6JL40SHA LA 6F 110CM JL40 Coronary Guiding cathet recall (Z-0949-06)Medtronic, Inc.2006-06-01
CATHETER LA6JL45A 6F 110CM JL4 CATHETER LA6JL45A 6F 110CM JL45 Coronary Guiding catheter d recall (Z-0950-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F JL5.0 110CM LAU CATHETER LA6JL50A LA 6F 110CM JL50 Coronary Guiding cathete recall (Z-0951-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F JR4.0 110CM LAU CATHETER LA6JR40A LA 6F 110CM JR40 Coronary Guiding cathete recall (Z-0952-06)Medtronic, Inc.2006-06-01
CATH.GUIDE 6F JR 4.0 SH 110CM CATHETER LA6JR40SHA LA 6F 110CM JR40 Coronary Guiding cathet recall (Z-0953-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F JR5.0 110CM LAU CATHETER LA6JR50A LA 6F 110CM JR50 Coronary Guiding cathete recall (Z-0954-06)Medtronic, Inc.2006-06-01
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Every clearance here is in the API, with alerts when new ones post.