Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Medtronic medical devices: approvals, recalls and adverse events

Stock: MDT. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

2,018

De Novo: 4

PMA approvals

12,222 supplements

Recalled products

2,538

491 class I

Adverse event reports

3.1M

41,361 deaths reported

How many recalls does Medtronic have?

Medtronic has 2,538 recalled medical device products in 777 recall actions in the records, 491 of them class I (the most serious kind). The newest recall started on Jun 24, 2026. In 2025 it had 29 recalled products.

How many medical devices has Medtronic had cleared or approved?

2,018 510(k) clearances, 4 De Novo grants and 94 original PMA approvals for high-risk devices, plus 12,222 PMA supplements (changes to approved devices). The newest decision was on Sep 17, 2026.

How many adverse event reports name Medtronic devices?

3,084,971 reports in total: 41,361 deaths, 812,135 injuries and 2,225,258 malfunctions were reported. 275,856 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	35	0	0	325
2025	29	0	2	484
2024	28	0	1	489
2023

Newest clearances and approvals

Protégé EverFlex Self-expanding Peripheral Stent System
K262913 · 510(k) clearance · Sep 17, 2026
LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
K261070 · 510(k) clearance · Sep 15, 2026
ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Bl...
K262235 · 510(k) clearance · Sep 4, 2026
LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
K262735 · 510(k) clearance · Aug 28, 2026
Affera Integrated Mapping System
K262005 · 510(k) clearance · Aug 21, 2026
NC Euphora Rapid Exchange Balloon Dilatation Catheter
K261428 · 510(k) clearance · Aug 14, 2026
BIS Advance pEEG Module
K260907 · 510(k) clearance · Aug 13, 2026
VitalFlow Set with Balance Biosurface
K261335 · 510(k) clearance · Jul 31, 2026
Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
K261759 · 510(k) clearance · Jul 27, 2026
Catalyft PL Expandable Interbody System
K253011 · 510(k) clearance · Jul 17, 2026

Devices with the most adverse event reports

By product code, all years

Automated Insulin Dosing Device System, Single Hormonal Control (OZP, class 3)809,925
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (OYC, class 3)601,313
Automated Insulin Dosing , Threshold Suspend (OZO, class 3)264,316
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief (LGW, class 3)128,056
Permanent Pacemaker Electrode (DTB, class 3)102,757
Implantable Cardioverter Defibrillator (Non-Crt) (LWS, class 3)95,011
Stimulator, Electrical, Implantable, For Incontinence (EZW, class 3)75,681
Pump, Infusion, Implanted, Programmable (LKK, class 3)69,864
Pacemaker/Icd/Crt Non-Implanted Components

All device makers and procedures · MDT stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to MDT with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Class I	Reports	Deaths
2026	41	1	236,988	1,259
2025	29	6	275,856	1,996
2024	93	12	236,930	1,920
2023	225	150	243,841	2,217
2022	73	23	319,044	1,788
2021	172	32	196,166	1,471
2020	91	4	229,756	1,465
2019	280	204	235,181	1,514
2018	130	4	200,226	1,546
2017	104	10	184,121	1,420
2016	148	2	145,751	1,159
2015	135	5	155,028	1,649
2014	74	15	96,059	1,698
2013	77	20	61,121	1,541
2012	53	3	67,289	6,009

Newest recalls

V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2
Class II · Jun 24, 2026 · Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
Class II · Jun 24, 2026 · Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
Class II · Jun 24, 2026 · Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Numb
Class II · Jun 24, 2026 · Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Nu
Class II · Jun 24, 2026 · Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Class II · Jun 24, 2026 · Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Class II · Jun 24, 2026 · Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Class II · Jun 24, 2026 · Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to
V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 C
Class II · Jun 24, 2026 · Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Nu
Class II · Jun 24, 2026 · Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during