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Medtronic Vascular, Inc.

Medtronic Vascular, Inc. Recalls

All product recalls associated with Medtronic Vascular, Inc..

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Recall Summary

Total Recalls

606

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 281–300 of 606 recalls

Medtronic Vascular, Inc.: Valiant Navion Thoracic Stent Graft System. For endovasc...

Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

FDAFeb 12, 2021Nationwide• Medtronic Vascular, Inc.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Implantable cardioverter defibrillators (ICD): 1) Evera f...

A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

FDAFeb 3, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Condit...

Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.

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FDANov 15, 2020GA, NJ, PA• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number...

Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.

FDANov 15, 2020GA, NJ, PA• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional ...

Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.

FDANov 15, 2020GA, NJ, PA• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc.: CareLink Personal Software Therapy Management Software To...

Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.

FDANov 12, 2020Nationwide• Medtronic Inc.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Cobalt Implantable Cardioverter Defibrillators with Cardi...

Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.

FDANov 5, 2020Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

MEDTRONIC ATS MEDICAL, INC.: Cardioblate CryoFlex, Surgical Ablation Probe, Model Numb...

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

FDAOct 12, 2020Nationwide• MEDTRONIC ATS MEDICAL, INC.

Medtronic Inc.: The Guardian Connect App CSS7200 iOS - Product Usage: int...

As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.

FDAJul 15, 2020IN• Medtronic Inc.

Medtronic Inc.: Medtronic SynchroMed, Model A10

The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.

FDAJul 13, 2020Nationwide• Medtronic Inc.

Medtronic Xomed, Inc.: Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: T...

Laceration Risk

During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.

FDAJun 12, 2020Nationwide• Medtronic Xomed, Inc.

Medtronic Sofamor Danek USA Inc: Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 1...

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

FDAJun 8, 2020Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Navigation, Inc.: StealthStation" S7 System with Polaris Spectra Camera par...

There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or illnesses have been reported, If impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm.

FDAJun 5, 2020Nationwide• Medtronic Navigation, Inc.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

FDAJun 4, 2020Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c...

FDAJun 4, 2020Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CareLink SmartSync Device Manager, Model Number 24970A

FDAJun 4, 2020Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Azure S DR MRI, Model Number W3DR01

FDAJun 4, 2020Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Azure S SR MRI, Model Number W3SR01

FDAJun 4, 2020Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c...

FDAJun 4, 2020Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01

FDAJun 4, 2020Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)