Agency classClass IIOur severity:High FDA (Devices)·Z-0559-2021·Announced 2020-12-16

Medtronic Evolut R System Recalled for Potential Valve Leaflet Damage

Medtronic is recalling Evolut R System transcatheter aortic valves due to a potential risk of leaflet damage during post-implant balloon dilatation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Medtronic Heart Valves Division is recalling the Evolut (TM) R System, a transcatheter aortic valve (TAV) device, due to a potential for leaflet damage. The recall affects specific model numbers including EVOLUTR-23, EVOLUTR-26, EVOLUTR-29, and EVOLUTR-34, along with their associated variants. The hazard is identified as the potential for damage to the valve leaflets when a post-implant balloon dilatation (PID) procedure is performed.

The recall covers 172,851 units that were distributed worldwide, including nationwide distribution in the United States and in numerous other countries such as Panama, Denmark, Austria, Germany, Finland, Sweden, Colombia, India, Mexico, Brazil, Spain, the United Kingdom, Australia, Ireland, Italy, Argentina, Japan, Poland, the Russian Federation, Hungary, Kazakhstan, Luxembourg, Portugal, Norway, Egypt, and Saudi Arabia. The agency has classified this recall as Class II.

Healthcare providers and patients should be aware of this potential risk. The source text does not specify specific consumer actions beyond the identification of the hazard and the affected units. Users should refer to the manufacturer's instructions and consult with their medical provider regarding the use of the device and the performance of post-implant balloon dilatation.

The recalled product

Product: Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT…
Manufacturer: Medtronic Heart Valves Division
Category: Medical Device — Cardiovascular
Hazard: device-defect
leaflet-damage
Affected units: 172,851

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 →

Same manufacturer · Medtronic Heart Valves Division

See all →

Severe
Medtronic Harmony Delivery Catheter System Distal Tip Detachment Risk
FDA (Devices) · 2026-07-08
High
Medtronic CoreValve Evolut PRO Delivery Catheter Actuator Separation Recall
FDA (Devices) · 2021-07-14
High
Medtronic CoreValve Evolut R Delivery Catheter System Recalled for Actuator Separation
FDA (Devices) · 2021-07-14
High
CoreValve Evolut PRO PLUS Delivery Catheter Systems recalled for actuator separation
FDA (Devices) · 2021-07-14
High
Medtronic Evolut PRO System Recalled for Potential Valve Leaflet Damage
FDA (Devices) · 2020-12-16

Same hazard · device defect