Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls
Every recall we track for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — 198 in all, from 2017–2023 — 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., Cardiac Rhythm and Heart Failure (CRHF) peaked in 2023 (120); 198 since 2017. 1% rated “stop using now”.
All FDA recall records for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 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 | 2 | 5 | 0 | 1 | 8 |
| 2018 | 0 | 5 | 5 | 3 | 13 |
| 2019 | 0 | 3 | 10 | 3 | 16 |
| 2020 | 0 | 0 | 15 | 0 | 15 |
| 2021 | 0 | 2 | 12 | 2 | 16 |
| 2022 | 0 | 3 | 7 | 0 | 10 |
| 2023 | 0 | 2 | 118 | 0 | 120 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 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., Cardiac Rhythm and Heart Failure (CRHF) recalls
30 shown- Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
Medtronic recalls specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a glassed feedthrough that may cause reduced or no energy output during high voltage therapy. Affected models include ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL with serial numbers listed.
MedtronicMay 10, 2023 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model
Medtronic CRHF devices for cardiac rhythm and heart failure management. Learn about the latest innovations in cardiac care.
MedtronicJun 22, 2022 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant
Medtronic recalls specific lots of C304-HIS devices due to potential sterility compromise from improperly sealed barriers. Affected units may pose infection risks during implant procedures.
MedtronicApr 20, 2022 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4;
Medtronic Crome models loaded with CareLink SmartSync Device Manager software D00U005 have a telemetry error that may cause issues with implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
MedtronicApr 12, 2022 - Use cautionMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls LINQ II Insertable Cardiac Monitor
Medtronic recalls 8 LINQ II Insertable Cardiac Monitors that may lose functionality due to moisture ingress. Affected devices have specific serial numbers and GTINs.
MedtronicJan 18, 2022 - Use cautionMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Medtronic recalls all Abre Venous Self-Expanding Stent Systems due to reports of stent migration. Learn if your device is affected and what to do.
MedtronicNov 19, 2021 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Medtronic recalls certain Sprint Quattro Lead Medical Device Identification Cards that incorrectly state patients have complete MR conditional systems. This could lead to unsafe MRI scans if the patient is mistakenly told they are MR safe.
MedtronicNov 8, 2021 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and
Medtronic recalls CareLink SmartSync Device Manager software (D00U005) for Cobalt and Crome ICDs/CRT-Ds due to potential data processing failures. Affected units may not correctly track heart health episodes.
MedtronicOct 12, 2021 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls C315-HIS Delivery Catheter
Medtronic recalls unused C315HIS Delivery Catheters (lots 0010567341, 10568899, 10568900) due to inability to pass a lead through the catheter. Affected users should contact Medtronic for details.
MedtronicSep 9, 2021 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Reveal LINQ LNQ11 / PA96000
Medtronic recalls Reveal LINQ LNQ11/PA96000 devices made on or after Feb 23, 2017 that may not detect and report heart rhythm issues to doctors.
MedtronicJun 1, 2021 - Use cautionMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Medtronic recalls LINQ II Model LNQ22 cardiac monitors that may fail to detect critical heart episodes after a reset. Owners should contact Medtronic for guidance.
MedtronicMay 14, 2021 - UnratedMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) -
Medtronic recalls Cobalt HF Quad MRI SureScan CRT-D devices with possible missing welds that could cause device failure. Affected units have specific serial numbers and product numbers.
Medtr: Cardiac RhythmApr 7, 2021 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally,
Medtronic recalls CareLink SmartSync Device Manager for potential longevity estimation errors in early device life when unipolar pacing vectors are programmed. No other features affected.
Medtr: CareLinkApr 6, 2021 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Medtronic recalls CareLink SmartSync Device Manager (24970A) due to software overestimating device longevity, potentially leading to premature replacement. All units with serial numbers are affected.
Medtr: CRHFApr 6, 2021 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT
Medtronic recalls certain implanted cardiac devices with cardiac resynchronization therapy (CRT-D) that may experience a shortened replacement time interval. Affected models include Viva, Claria, Amplia, Compia, and Brava families. No immediate action is required but monitoring is advised.
MedtronicFeb 3, 2021 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with
Medtronic recalls specific implantable defibrillators due to rare risk of device malfunction. Affected units have serial numbers RSN600251S and RSN600656S. No immediate action required per recall.
MedtronicNov 15, 2020 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Medtronic recalls specific Cobalt CRT-D defibrillators due to a potential manufacturing error in cathode components, though all devices passed functional tests.
MedtronicNov 5, 2020 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
Medtronic recalls Percepta CRT-P MRI devices with specific model numbers due to a rare temporary suspension of device features during certain device interrogations. Features automatically resume after next interrogation or magnet presence. No patient impact expected.
MedtronicJun 4, 2020 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as
Medtronic recalls CareLink 2090 Programmer devices with specific serial numbers due to two cyber vulnerabilities: improper access control and cleartext transmission of sensitive health information. Affected units may expose patient data to unauthorized access.
MedtronicJan 30, 2020 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
Medtronic CareLink Encore Programmer (serial numbers listed) may display inaccurate remaining battery life for some implanted cardiac devices. This does not affect device function but could lead to unexpected battery depletion. No action is required for most users.
MedtronicOct 3, 2019 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
Medtronic is recalling specific Micra pacemaker models (MC1VR01) for updated instructions on removing the tether during implant. This recall affects certain serial numbers sold only in the U.S. and requires updated instructions for safe implant procedures.
MedtronicAug 6, 2019 - Use cautionMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation
Medtronic recalls PVAC GOLD catheters (990078) produced in past 18 months without updated instructions to reduce phrenic nerve injury risk during heart procedures.
MedtronicMar 4, 2019 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls MEDTRONIC CARELINK 2090 programmer
Medtronic is recalling CareLink 2090 programmers with specific serial numbers due to an error in calculating and displaying the remaining time before the device should be replaced. This could cause users to replace their device too early or too late. Affected units include those with serial numbers listed in the recall notice.
MedtronicJan 17, 2019 - Use cautionMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Recall of Medtronic Power Supply 26907 and CareLink Encore 29901 Programmer due to potential electrical short circuits causing overheating, smoke, and disconnection. Affected units have specific serial numbers.
MedtronicJan 17, 2019 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number
Medtronic recalls specific dual chamber pacemaker models (RED01, REDR01, REVDD01) distributed 2017-2019 that may experience circuit errors affecting device function. Owners should contact Medtronic for details.
MedtronicJan 17, 2019 - UnratedMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic CareLink Encore 29901 Programmer
Medtronic recalls CareLink Encore 29901 programmers due to potential cybersecurity risks allowing unauthorized software updates. All units are affected.
MedtronicOct 2, 2018 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and
Medtronic recalls EnTrust dual-chamber ICDs with potential loss of heart therapy as battery capacity drops near replacement. Affected devices may show end-of-life warnings without prior alerts.
MedtronicJun 21, 2018 - Lower riskMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac
Medtronic recalls Percepta CRT-P MRI SureScan devices with specific serial numbers due to a potential reset risk from timing interactions between the EffectivCRT Diagnostic and Ventricular Safety Pacing feature. Affected units include those with serial numbers listed in the recall notice.
MedtronicJun 21, 2018 - Use cautionMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Single Chamber Temporary External Pacemaker, Model 53401
Medtronic recalls Model 53401 Single Chamber Temporary External Pacemakers with specific serial numbers due to potential power reset causing setting reversion during patient use.
MedtronicJun 6, 2018 - Use cautionMedical device
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1
Medtronic recalls specific implantable heart devices (ICDs) due to possible failure to prevent high and low voltage therapy. Affected models include Evera MRI XT DR ICD DF1 and others with listed product numbers and serials.
MedtronicDec 19, 2017
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recall questions
How many recalls has Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) had?
198 recalls from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) are on record with U.S. safety agencies, from 2017–2023.
What is the most recent Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recall?
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators, dated May 10, 2023. Every Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recall is listed on this page, newest first.
What should I do if I have a recalled Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 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., Cardiac Rhythm and Heart Failure (CRHF) 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.