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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate."
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.
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