FDA Reports Class 1 Recall of Medtronic Loading System for TAVR Device

Deborah Brauser

August 07, 2015

SILVER SPRING, MD — Medtronic is voluntarily recalling its EnVeo R Loading System, which is used with its CoreValve Evolut R system for TAVR, according to the US Food and Drug Administration (FDA)[1].

The manufacturer received eight reports about the presence of particulates in the EnVeo R Loading System, which "has the potential to be transferred to the transcatheter aortic valve and released into the patient's vasculature." Two of the reports involved particulates observed in the packaged kits, whereas the other six involved particulates observed in the loading bath. However, no adverse events have been noted at this time.

According to Medtronic, the company sent out letters to healthcare professionals regarding 6912 units in the field, of which 540 were in the US. The manufacturer letters, dated July 2015, explained that only specific lots of the loading system were affected and told customers how to contact the company.

"Medtronic is not making any special patient management recommendations; patients should continue to be managed in accordance with your standard patient-management protocol," the company writes in the letter, which is titled "Urgent Field Safety Notice."

In an email to heartwire from Medscape, a representative from the company noted that none of the affected loading systems were released commercially in the US and were being used only in clinical trials. All have now been removed from the market.

The affected system works with the Evolut device, which was approved by the FDA earlier this summer for TAVR in patients with severe aortic stenosis[2].

The new recall was given a class 1 designation from the FDA, signifying that there's a "reasonable probability" that use of the product can cause serious health consequences or even death.

However, the issue has now "been resolved with the introduction of a process improvement in manufacturing," the Medtronic rep told heartwire .


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