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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recalls

All product recalls associated with Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF).

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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 241–260 of 606 recalls

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): C315-HIS Delivery Catheter

Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.

FDASep 9, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Sofamor Danek USA Inc: Endoskeleton" TCS Interbody System with Titan nanoLOCK" S...

Engraving on implants may not match what is listed on the pouch labels.

FDASep 2, 2021CA, IN, MN +12 more• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Endoskeleton" TAS Interbody System with Titan nanoLOCK" S...

Engraving on implants may not match what is listed on the pouch labels.

FDASep 2, 2021CA, IN, MN +12 more

1...11 121314 15...31

Page 13 of 31Next

• Medtronic Sofamor Danek USA Inc

Medtronic Xomed, Inc.: Medtronic sterile single-use blades that are components o...

There was an increase in complaints related to tip breaks and wobble/vibration.

FDAAug 31, 2021Nationwide• Medtronic Xomed, Inc.

Medtronic Vascular, Inc.: Endurant II/Endurant IIs Stent Graft System: Medtronic E...

During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

FDAJun 7, 2021GA, MD, MA +5 more• Medtronic Vascular, Inc.

Medtronic Vascular, Inc.: Medtronic Endurant IIs Stent Graft System Medtronic Endu...

During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

FDAJun 7, 2021GA, MD, MA +5 more• Medtronic Vascular, Inc.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic Reveal LINQ LNQ11 / PA96000

Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.

FDAJun 1, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac...

Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.

FDAMay 14, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Vascular, Inc.: Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C...

Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.

FDAApr 28, 2021Nationwide• Medtronic Vascular, Inc.

Medtronic Sofamor Danek USA, Inc: Braive Growth Modulation System Break-Off Set Screws - Pr...

Product is impacted by a thread profile defect due to a manufacturing issue.

FDAApr 27, 2021IN• Medtronic Sofamor Danek USA, Inc

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Cobalt HF Quad MRI SureScan Implantable Cardioverter Defi...

The device may contain a manufacturing defect of a missing resistance spot weld (RSW).

FDAApr 7, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CareLink SmartSync Device Manager - Product Usage: used t...

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Implantable Pulse Generators - Product Usage: used to tre...

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01...

There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Programmers - Product Usage: used to treat arrhythmias re...

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Implantable cardiac resynchronization therapy pacemakers ...

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CareLink SmartSync Device Manager (24970A). used to inte...

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc.: VenaSeal Closure System

Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

FDAMar 23, 2021Nationwide• Medtronic Inc.

Medtronic Sofamor Danek USA, Inc: Endoskeleton TC Interbody System with Titan nanoLOCK Surf...

The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

FDAMar 17, 2021Nationwide• Medtronic Sofamor Danek USA, Inc

Medtronic Inc.: Medtronic Abre Venous Self-expanding Sent System, Catalog...

Incorrect size printed on the device; packaging is labeled correctly.

FDAMar 16, 2021Nationwide• Medtronic Inc.