Medtronic Recalls EnVeo R Loading Systems Due to Particulate Presence
Medtronic is recalling EnVeo R Loading Systems because of the presence of particulate. The recall affects 6,912 units worldwide, including 540 in the US.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is FDA Class I, which is defined as unlikely to cause adverse health consequences. The source text does not report any injuries, illnesses, or deaths, and the hazard is limited to the presence of particulate without further specified risk.
Plain-English summary
Medtronic Cardiovascular Surgery-the Heart Valve Division is recalling the EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, and LS-EnVeoR-2629-C. These are cardiovascular valve delivery systems used with the Medtronic CoreValve Evolut R system. The recall is being conducted because of the presence of particulate in the devices.
A total of 6,912 units are affected by this recall, with 540 units distributed in the United States. The remaining units were distributed worldwide, including in Australia, Austria, Belgium, Canada, and other listed countries. Specific lot numbers are provided in the official recall documentation.
Healthcare providers and consumers should stop using the affected EnVeo R Loading Systems immediately. Medtronic is the recalling firm responsible for managing the recall process. No specific instructions for return or replacement are detailed in the provided source text, but users should follow the official recall guidance from Medtronic or the FDA.
The recalled product
- Product
- EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medtronic Cardiovascular Surgery-the Heart Valve Division
See all →- HighMedtronic EnVeo Delivery Catheter System Recalled for Vascular Trauma Risk
FDA (Devices) · 2016-08-24
- ModerateMedtronic Recalls Hancock Apical Left Ventricle Connectors Due to Production Discontinuation
FDA (Devices) · 2014-09-17
- SevereMedtronic Mosaic Aortic Obturator Recalled for High Transvalvular Gradients
FDA (Devices) · 2014-02-12
Same hazard · particulate contamination
See all →- CriticalCardiovascular Procedure Kits Recalled Due to Particulate in Fluid Path
FDA (Devices) · 2026-08-05
- HighLidocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateFDA Recalls Xylocaine Injections Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- SevereMedline Medical Convenience Kits with Namic Manifold Fluid Contamination
FDA (Devices) · 2026-05-20
- SevereMedline Medical Convenience Kits with Namic Manifold recalled
FDA (Devices) · 2026-05-20