Medtronic recalls Evolut R System heart valves with model numbers EVOLUTR-23 to EVOLUTR-34. Potential for valve leaflet damage during post-implant balloon dilatation may cause complications.
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Medtronic is recalling certain Evolut R System heart valves that could be damaged during a post-implant balloon dilatation procedure. This risk may lead to complications for patients who have received the valve implant.
During a post-implant balloon dilatation procedure, the valve's leaflets could be damaged, potentially causing complications. This risk occurs when the valve is inflated with a balloon to expand it properly after implantation.
Patients who received the recalled Evolut R System heart valves during implantation are most at risk. The recall applies to specific model numbers sold between 2019 and 2020.
Check your valve's model number on the label. The recalled models include EVOLUTR-23, EVOLUTR-23-C, EVOLUTR-23-US, EVOLUTR-26, EVOLUTR-26-C, EVOLUTR-26-US, EVOLUTR-29, EVOLUTR-29-C, EVOLUTR-29-US, and EVOLUTR-34 series.
Look for the model number on the valve label, which should match the listed models (EVOLUTR-23 to EVOLUTR-34).
If you have the recalled valve, contact your doctor to discuss the potential risk and next steps.
Medtronic recalls these valves because there is a potential for damage to the valve's leaflets during a post-implant balloon dilatation procedure, which could lead to complications.
The affected models include EVOLUTR-23, EVOLUTR-23-C, EVOLUTR-23-US, EVOLUTR-26, EVOLUTR-26-C, EVOLUTR-26-US, EVOLUTR-29, EVOLUTR-29-C, EVOLUTR-29-US, and EVOLUTR-34 series.
If you have the recalled valve, contact your doctor to discuss the potential risk and whether any action is needed.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0559-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0559-2021 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
