Medtronic, Inc. recalls
Every recall we track for Medtronic, Inc. — 98 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Medtronic, Inc. fell by more than half in 2025 (7, down from 25 in 2024). 2% rated “stop using now”.
All FDA recall records for Medtronic, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 1 | 4 | 3 | 0 | 8 |
| 2018 | 0 | 2 | 3 | 1 | 6 |
| 2019 | 0 | 4 | 6 | 0 | 10 |
| 2020 | 0 | 5 | 2 | 0 | 7 |
| 2021 | 0 | 10 | 12 | 0 | 22 |
| 2022 | 0 | 2 | 3 | 1 | 6 |
| 2023 | 0 | 0 | 6 | 0 | 6 |
| 2024 | 0 | 3 | 16 | 6 | 25 |
| 2025 | 1 | 1 | 4 | 1 | 7 |
| 2026 (to date) | 0 | 1 | 0 | 0 | 1 |
Most common reasons for Medtronic, Inc. recalls
What to do if you have a recalled Medtronic, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Medtronic, Inc. recalls
39 shown- Use cautionMedical device
Medtronic, Inc. recalls Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial
Medtronic recalls Sphere-9 catheters (model AFR-00001) for patients with Biotronik ICDs or CRT-Ds due to risk of ventricular fibrillation during radiofrequency therapy. Medtronic recommends increased caution and availability of external defibrillation systems.
MedtronicMar 11, 2026 - UnratedMedical device
Medtronic Inc recalls Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090
Medtronic recalls specific Abre Venous Self-Expanding Stent models due to a Nitinol anomaly that may reduce stent diameter and cause migration. Affected models include AB9G14120090 and others listed in the recall notice.
MedtronicDec 4, 2025 - Lower riskMedical device
Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product
Medtronic EVX 60 Series: Advanced medical devices for healthcare applications. Explore the latest EVX 60 Series products and solutions.
MedtronicOct 29, 2025 - Use cautionMedical device
Medtronic, Inc. recalls Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt
Medtronic recalls specific software versions of CareLink SmartSync Patient Connector Model 24967 due to a risk of unintended high-voltage therapy delivery during induction tests. Affected units may not properly cancel high-voltage treatments if the Abort button fails to stop the test.
MedtronicJun 18, 2025 - Lower riskMedical device
Medtronic, Inc. recalls Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software
Medtronic recalls SmartSync Patient Connectors with specific software versions due to potential erroneous reset messages that could lead to unnecessary device explant. 39 reports of this error exist.
MedtronicJun 17, 2025 - Stop using nowMedical device
Medtronic, Inc. recalls Azure S DR MRI SureScan, Product number W3DR01
Medtronic recalls Azure S DR MRI SureScan devices with specific serial numbers due to potential battery failure that could lead to cardiac arrest or hospitalization. Affected units must be checked for serial numbers RNJ108800G to RNJ108820G.
MedtronicApr 29, 2025 - Use cautionMedical device
Medtronic Inc. recalls 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE
Medtronic recalls 2090 Programmers with serial number prefixes PKK0 and PKK1 that may move cursor autonomously when Finger Touchscreen is enabled in software version 3.2 or higher. Affected units include specific model variants and GTINs.
MedtronicJul 11, 2024 - Use cautionMedical device
Medtronic Inc. recalls EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Medtronic recalls specific model implantable defibrillators due to potential weld cracks causing manufacturing failures. Affected units have unique serial numbers; contact Medtronic for details.
MedtronicApr 16, 2024 - UnratedMedical device
Medtronic Inc. recalls Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Medtronic recalls specific Abre Venous Self-expanding Stent Systems due to potential sterile package breach. Affected product numbers include AB9U14080090, AB9U18100090, and AB9G14100090. No remedy is specified in the recall notice.
MedtronicFeb 16, 2024 - Lower riskMedical device
Medtronic Inc. recalls Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Medtronic recalls Cobalt XT DR MRI SureScan defibrillators with product number DDPA2D1 due to potential battery retesting during quality checks, which may affect safety.
MedtronicDec 7, 2023 - Lower riskMedical device
Medtronic Inc. recalls Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Medtronic recalls Protege GPS Self-Expanding Peripheral Stent System (product number SERB65-09-60-80) due to potential packaging seal defects that could compromise sterility. Affected units include lot B644679 with UDI-DI 00643169728974.
MedtronicNov 20, 2023 - Lower riskMedical device
Medtronic Inc. recalls ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Medtronic recalls specific models of ICM LNQ22 LINQ II insertable cardiac monitors due to potential signal interference that may affect heart rhythm recordings. This issue differs from normal noise patterns caused by device movement or external factors.
MedtronicNov 3, 2023 - Lower riskMedical device
Medtronic Inc recalls Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Medtronic recalls Mo.Ma Ultra Proximal Cerebral Protection Device model MOM0130069X6 due to incorrect port labeling that could lead to improper use during medical procedures.
MedtronicOct 12, 2023 - Use cautionMedical device
Medtronic Inc. recalls EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Medtronic recalls EverFlex Self-Expanding Peripheral Stents with Entrust Delivery System due to potential partial deployment risks. Affected models include 158 specific model numbers and GTINs.
MedtronicJul 14, 2022 - Lower riskMedical device
Medtronic Inc recalls Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a
Medtronic recalls Sprinter OTW catheter model SPR2512W due to incorrect balloon size labeling on the Luer connector. This may lead to improper sizing during procedures. Affected units were sold with specific lot numbers.
MedtronicJun 24, 2022 - Lower riskMedical device
Medtronic Inc recalls HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Medtronic recalls HeartWare Battery Model 1650DE (serial numbers listed) due to weld defect causing battery malfunction. No power or improper charging may occur.
MedtronicMay 5, 2022 - UnratedMedical device
Medtronic Inc recalls HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Medtronic recalls HeartWare HVAD Pump Implant Kit models 1104JP and MCS1705PU due to suspected welding defects that could cause pump malfunction and affect blood flow.
MedtronicApr 14, 2022 - Lower riskMedical device
Medtronic Inc recalls Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD)
Medtronic recalls instructions for use, patient manuals, and emergency responder guides for HeartWare Ventricular Assist Device (HVAD) systems due to errors and inconsistencies in documentation. Affected models include specific pump implant kits and catalog numbers.
MedtronicMar 30, 2022 - Use cautionMedical device
Medtronic Inc recalls Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation
Medtronic recalls Harmony Delivery Catheter System (HARMONY-DCS) due to potential capsule bond breaking during TPV valve replacement procedures. Affected lots listed in the recall notice.
MedtronicMar 2, 2022 - Lower riskMedical device
Medtronic Inc. recalls VenaSeal Closure System
Medtronic recalls VenaSeal Closure System models SP-101 and VS-402/404 due to adhesive not advancing through delivery catheter. Affected units have specific serial numbers listed in the recall notice.
MedtronicMar 23, 2021 - Lower riskMedical device
Medtronic Inc. recalls Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in
Medtronic recalls Abre Venous Self-expanding System due to incorrect size printed on device, packaging labeled correctly. Affected units may have size mismatch risks.
MedtronicMar 16, 2021 - Lower riskMedical device
Medtronic Inc. recalls Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086,
Medtronic recalls Guardian Sensor kits for inaccurate glucose readings when used with hydroxyurea. Affected kits have specific packaging codes; no remedy provided in recall notice.
MedtronicFeb 26, 2021 - Use cautionMedical device
Medtronic Inc. recalls CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software
Medtronic recalls CareLink Personal Software versions 3.1.5.000 and 3.1.2.000 for diabetes management due to potential incomplete insulin rate data transmission and RF interference during data uploads.
MedtronicNov 12, 2020 - Lower riskMedical device
Medtronic Inc. recalls The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile
Medtronic recalls iOS app CSS7200 for patients with diabetes that stops automatically uploading glucose data to CareLink Personal website after software update.
MedtronicJul 15, 2020 - Lower riskMedical device
Medtronic Inc. recalls Medtronic SynchroMed, Model A10
Medtronic recalls SynchroMed Model A10 devices with software version 1.1.300 due to missing decimal separator in parameter displays, potentially causing misinterpretation of values.
MedtronicJul 13, 2020 - Use cautionMedical device
Medtronic Inc. recalls MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous
Medtronic recalls MiniMed 670G insulin pumps with serial numbers ending in H (e.g., NG2093124H) due to missing solder battery connection that could interrupt insulin delivery.
MedtronicApr 30, 2020 - Use cautionMedical device
Medtronic Inc. recalls Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Medtronic recalls insulin pumps with specific serial numbers due to potential endotoxin levels that could cause fever, hypotension, or life-threatening reactions. Affected pumps were produced from May 21, 2019 onward.
MedtronicApr 10, 2020 - Use cautionMedical device
Medtronic Inc. recalls Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and
Medtronic recalls specific MiniMed 630G System models with SmartGuard due to potential loose reservoir causing insulin delivery issues. Affected units may lead to hypoglycemia or hyperglycemia.
MedtronicNov 21, 2019 - Lower riskMedical device
Medtronic Inc recalls Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic
Medtronic recalls Hancock II T510 mitral bioprosthesis devices with mislabeled sizes that could lead to improper valve fitting during surgery.
Medtr: a short, human brand name for headings (e.g. "Trsmima")May 21, 2019 - Lower riskMedical device
Medtronic Inc. recalls Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Medtronic recalls Guardian Connect app and transmitter for iPhone/iPad/iPod Touch with iOS 12, causing shorter battery life (4-5 days vs 7+ days).
MedtronicMay 20, 2019 - Use cautionMedical device
Medtronic Inc. recalls Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G
Medtronic recalls insulin pumps with version 4.10 software that may fail to make audio alerts for system notifications or glucose alerts, potentially causing users to miss critical warnings.
MedtronicOct 3, 2018 - UnratedMedical device
Medtronic Inc. recalls Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm
Medtronic recalls Minimed Model 503 Remote Transmitters for potential security risks with insulin pumps. Affected units may have vulnerabilities that could compromise patient safety.
MedtronicAug 7, 2018 - Use cautionMedical device
Medtronic Inc. recalls Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Medtronic recalls Guardian Connect App CSS7200 for iPhone/iPad/iPod Touch. The app may close without alerting users to hypoglycemic or hyperglycemic events, risking missed blood sugar alerts.
MedtronicJul 4, 2018 - Lower riskMedical device
Medtronic Inc. recalls Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK
Medtronic recalls Contour Plus Link 2.4 wireless glucose meters with incorrect unit of measure (mg/dL instead of mmol/L) that could lead to inaccurate blood sugar readings for diabetes management.
MedtronicMay 16, 2018 - Lower riskMedical device
Medtronic Inc. recalls Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
Medtronic recalls MiniMed Paradigm Veo insulin pumps with catalog numbers MMT-554 and MMT-754 that have an Arabic language translation error in the Predictive Alerts setting screen. This error may cause incorrect alerts for low or high glucose levels.
MedtronicApr 24, 2018 - Lower riskMedical device
Medtronic Inc. recalls Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the
Medtronic recalls Everflex Self-Expanding Peripheral Stents with Entrust Delivery System due to potential label length mismatch. Affected models include EVD35-07-060-120 and EVD35-07-120-120. Contact Medtronic for details.
MedtronicNov 3, 2017 - Lower riskMedical device
Medtronic Inc. recalls Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model,
Medtronic recalls CareLink iPro Therapy Management Software (MMT-7340) due to incorrect glucose reports generated between Sept 23-27, 2017 using the new Uploader feature. Affected healthcare professionals should verify reports from that period.
MedtronicOct 10, 2017 - Use cautionMedical device
Medtronic Inc recalls 6F Taiga Guiding Catheter
Medtronic recalls 6F Taiga Guiding Catheter with specific lot/serial numbers due to complaints of tip detachment and splitting. Affected users should check their device details.
MedtronicSep 26, 2017 - Use cautionMedical device
Medtronic Inc. recalls Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
Medtronic recalls MiniMed Pro-set (MMT-280, 281) due to potential insulin over-delivery. Affected units include specific lot numbers. Consumers should contact Medtronic for details.
MedtronicSep 10, 2017
Medtronic, Inc. recall questions
How many recalls has Medtronic, Inc. had?
98 recalls from Medtronic, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Medtronic, Inc. recall?
Medtronic, Inc. recalls Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial, dated Mar 11, 2026. Every Medtronic, Inc. recall is listed on this page, newest first.
Why are Medtronic, Inc. products recalled?
The most common reasons on record: Missing solder battery connection, which could interrupt power of insulin pump. (3).
What should I do if I have a recalled Medtronic, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Medtronic, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.