Medtronic Evolut PRO+ System Recalled for Valve Leaflet Damage Risk
Medtronic is recalling 19,961 Evolut PRO+ Transcatheter Aortic Valve systems due to a potential for 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. The hazard involves a potential for device damage (leaflet damage) during a specific procedure, which represents a risk of harm to patients, but the source text does not report specific injuries, hospitalizations, or fatalities.
Plain-English summary
Medtronic Heart Valves Division is recalling 19,961 units of the Evolut (TM) PRO+ System. The recall involves specific model numbers including EVPROPLUS-23US, EVPROPLUS-26US, EVPROPLUS-29US, and EVPROPLUS-34US, along with their associated labeled variants.
The recall is being conducted 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 valve has been implanted.
The affected devices were distributed worldwide, including nationwide distribution in the United States and in 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. Healthcare providers and patients should consult with their medical professionals regarding the status of any implanted devices and potential risks associated with post-implant procedures.
The recalled product
- Product
- Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV E
- Manufacturer
- Medtronic Heart Valves Division
- Category
- Medical Device — Cardiovascular
- Affected units
- 19,961
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.
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