Medtronic recalls Evolut PRO+ System models EVPROPLUS-23US to EVPROPLUS-34US due to potential TAV leaflet damage during balloon dilatation. Affected patients should contact Medtronic for guidance.
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Medtronic is recalling its Evolut PRO+ System heart valve models because they could cause damage to the valve's leaflets during a balloon dilatation procedure. This risk may lead to complications after the valve is implanted.
The valve's leaflets could be damaged during a balloon dilatation procedure after implantation. This damage might cause the valve to malfunction or require additional surgery.
Patients who received the Evolut PRO+ System heart valve (models EVPROPLUS-23US to EVPROPLUS-34US) are affected. Those with the valve implanted are most at risk during follow-up procedures.
Check the model number on your valve's packaging or label. The affected models are EVPROPLUS-23US, EVPROPLUS-26US, EVPROPLUS-29US, and EVPROPLUS-34US.
Reach out to Medtronic directly for guidance on next steps after identifying the affected model.
The affected models are EVPROPLUS-23US, EVPROPLUS-26US, EVPROPLUS-29US, and EVPROPLUS-34US.
The recall is due to a potential risk of TAV leaflet damage during balloon dilatation after implantation.
No, but patients should contact Medtronic for guidance on next steps as the valve may need special care during follow-up procedures.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0561-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0561-2021 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.
