PlainRecalls

Medtronic Inc

Compiled from official public sources by the publisher.

109 recalls on record · Latest: May 6, 2026

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Agency notice ledger

Federal filing book Medtronic Inc HEAVY-BOOK · SINGLE-AGENCY

#150 of 14,151 · 109 notices · 0.104% archive

  • BOOK 109 notices
  • RANK #150 of 14,151
  • SHARE 0.104% archive
  • AGENCY FDA Devices (109)
  • CAT medical devices
  • CATS 1 category
  • LATEST May 6, 2026
  • PHOTO Ameditech Inc

Nearest notice-volume peer: Ameditech Inc (0 notice gap)

Medtronic Inc accounts for about 0.104% of the 104,423-notice archive on 109 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Medtronic Inc's standing among 14,151 recalling firms

Medtronic Inc ranks 150th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Medtronic Inc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

109 150th of 14151 higher than 14,000 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Medtronic Inc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Medtronic Inc holds about 0.104% of archive notices alongside 109 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate May 6, 2026

Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
FDA Devices Moderate Jan 21, 2026

Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
FDA Devices Moderate Dec 10, 2025

Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
FDA Devices Moderate Jul 30, 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, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
FDA Devices Moderate Jul 30, 2025

Medtronic CareLink SmartSync Device Manager, Model Number 24967A 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, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
FDA Devices Moderate Jul 23, 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. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Sof
FDA Devices Moderate Jul 23, 2025

Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A 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. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura applicati
FDA Devices Moderate Jun 18, 2025

Azure S DR MRI SureScan, Product number W3DR01
FDA Devices Moderate Sep 25, 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; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Pro
FDA Devices Moderate Jul 3, 2024

EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D4. f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1. g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ. h. COMPIA MRI QUAD
FDA Devices Moderate Jul 3, 2024

COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024

EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Mar 27, 2024

Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
FDA Devices Moderate Jan 31, 2024

Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
FDA Devices Moderate Jan 10, 2024

Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
FDA Devices Moderate Dec 20, 2023

Medtronic SynchroMed, Model A10
FDA Devices Moderate Dec 6, 2023

ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
FDA Devices Moderate Nov 29, 2023

Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
FDA Devices Moderate Nov 29, 2023

Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
FDA Devices Moderate Nov 29, 2023

Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
FDA Devices Moderate Sep 7, 2022

EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
FDA Devices Moderate Aug 10, 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.
FDA Devices Critical Jun 29, 2022

HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
FDA Devices Critical Jun 15, 2022

HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
FDA Devices Moderate May 25, 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 Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001
FDA Devices Critical Apr 27, 2022

Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
FDA Devices Moderate May 26, 2021

Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTIN: 20763000243368 GS3 5PK 9L OUS3/ GTIN: 20763000318882 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

Medtronic Inc carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (109 here — heavy-book).

Ameditech Inc 109 Stryker Neurovascular 109 Sca Pharmaceuticals 107 Carefusion 2200 Inc 112 Steris Corporation 112

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Ameditech Inc 109 Stryker Neurovascular 109 Carefusion 2200 Inc 112 Steris Corporation 112

Frequently Asked Questions

How many federal recall notices name Medtronic Inc? ▼
PlainRecalls indexes 109 distinct federal recall events naming Medtronic Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Medtronic Inc sit among other recalling firms? ▼
Medtronic Inc ranks #150 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Medtronic Inc's notices? ▼
FDA Devices accounts for 109 of this firm's 109 indexed notices.
What product category dominates Medtronic Inc's filing book? ▼
Filings for Medtronic Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Medtronic Inc: 109 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Medtronic Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026