The Recall Desk
HighFDA (Devices)·Z-0560-2021·Announced 2020-12-16

Medtronic Evolut PRO System Recalled for Potential Valve Leaflet Damage

Medtronic is recalling 71,030 Evolut PRO System units worldwide due to a potential for transcatheter aortic valve leaflet damage during post-implant balloon dilatation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (leaflet damage) in a medical device where no injuries or illnesses have been explicitly reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Medtronic Heart Valves Division is recalling 71,030 units of the Evolut (TM) PRO System. The recall includes specific model numbers such as EVOLUTPRO-23, EVOLUTPRO-26, and EVOLUTPRO-29, along with their associated US and international variants. The affected devices were distributed worldwide, including in the United States and numerous other countries such as Panama, Denmark, Austria, Germany, and Japan.

The recall is being issued because of a potential for transcatheter aortic valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID). This procedure is a specific medical intervention performed after the initial implantation of the valve system. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

Healthcare providers and patients who have received the Evolut PRO System should consult with their medical providers regarding the recall and any necessary follow-up care. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV EVOLUTPRO-23 BLUE 6L COMM OUS, VLV EVOLUTPRO-23 PRO COMM 29L CAN, VLV EVOLUTPRO-
Manufacturer
Medtronic Heart Valves Division
Category
Medical Device — Cardiovascular
Hazard
Affected units
71,030

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Medtronic Heart Valves Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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