Medtronic, Inc.

FDA recalling firm · 47 enforcement events · 109 product records · 2015–2026 · MN, CA

Medtronic, Inc. has 47 FDA enforcement events on this register (109 product records) between 2015 and 2026: 47 device; the busiest year was 2017 with 6.

13% of its events are Class I; the most common class is Class II (40). 25 events are listed as ongoing; the recalling firm's address is in MN and CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
11 Mar 2026	Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.	Device	Class II	1	Ongoing
4 Dec 2025	Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090	Device	Class II	1	Ongoing
29 Oct 2025	Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4	Device	Class II	1	Ongoing
18 Jun 2025	Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application,…	Device	Class II	2	Ongoing
17 Jun 2025	Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4.…	Device	Class II	2	Ongoing
29 Apr 2025	Azure S DR MRI SureScan, Product number W3DR01	Device	Class II	1	Ongoing
11 Jul 2024	2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM;…	Device	Class II	1	Ongoing
16 Apr 2024	COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator	Device	Class II	23	Ongoing
16 Feb 2024	Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090	Device	Class II	1	Ongoing
7 Dec 2023	Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1	Device	Class II	1	Ongoing
20 Nov 2023	Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.	Device	Class II	1	Completed
3 Nov 2023	ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor	Device	Class II	1	Ongoing
12 Oct 2023	Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6	Device	Class II	3	Ongoing
14 Jul 2022	EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System	Device	Class II	1	Ongoing
24 Jun 2022	Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.	Device	Class II	1	Ongoing
5 May 2022	HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.	Device	Class I	1	Ongoing
14 Apr 2022	HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU	Device	Class I	1	Ongoing
30 Mar 2022	Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model…	Device	Class II	1	Ongoing
2 Mar 2022	Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.	Device	Class I	1	Ongoing
23 Mar 2021	VenaSeal Closure System	Device	Class III	1	Terminated
16 Mar 2021	Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.	Device	Class II	1	Terminated
26 Feb 2021	Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to…	Device	Class II	20	Ongoing
12 Nov 2020	CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000	Device	Class II	1	Ongoing
15 Jul 2020	The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.	Device	Class II	1	Terminated
13 Jul 2020	Medtronic SynchroMed, Model A10	Device	Class II	1	Completed
30 Apr 2020	MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter, the pump displays continuous sensor…	Device	Class II	3	Ongoing
10 Apr 2020	Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001	Device	Class II	1	Terminated
21 Nov 2019	Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only	Device	Class I	4	Ongoing
21 May 2019	Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.	Device	Class II	5	Terminated
20 May 2019	Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.	Device	Class II	1	Ongoing
3 Oct 2018	Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)	Device	Class II	1	Ongoing
7 Aug 2018	Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).	Device	Class I	2	Terminated
4 Jul 2018	Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.	Device	Class II	1	Terminated
16 May 2018	Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and control solution) is designed for self-testing by persons with diabetes and the monitoring of glucose concentrations for…	Device	Class II	1	Terminated
24 Apr 2018	Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754	Device	Class II	1	Terminated
3 Nov 2017	Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from…	Device	Class II	1	Terminated
10 Oct 2017	Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iPro software is used to upload glucose…	Device	Class II	1	Terminated
26 Sep 2017	6F Taiga Guiding Catheter	Device	Class I	1	Terminated
10 Sep 2017	Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)	Device	Class II	5	Ongoing
8 May 2017	MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.	Device	Class II	4	Terminated
31 Jan 2017	MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.	Device	Class II	1	Terminated
16 Nov 2016	Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extracorporeal perfusion…	Device	Class II	1	Terminated
10 Nov 2016	ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis…	Device	Class II	1	Terminated
5 Aug 2016	CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports…	Device	Class II	1	Terminated
23 Feb 2016	Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.	Device	Class II	1	Terminated
9 Nov 2015	Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.	Device	Class II	1	Terminated
29 Sep 2015	Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation…	Device	Class II	1	Terminated

By type and class

Device47

Class II40

Class I6

Class III1

Class I: 13% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Medtronic, Inc. by year initiated.

Questions and answers

How many FDA recalls has Medtronic, Inc. had?

47 enforcement events (109 product records) on this register, 2015–2026: 47 device.

Are any Medtronic, Inc. recalls ongoing?

25 events are listed as ongoing in the current openFDA export.

What class are Medtronic, Inc. recalls?

40 Class II, 6 Class I, 1 Class III. 13% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.