Medtronic recalls Evolut PRO System models EVOLUTPRO-23 to EVOLUTPRO-29 for potential valve leaflet damage during post-implant balloon dilatation, which could affect heart valve function.
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Medtronic is recalling Evolut PRO System heart valve devices with specific model numbers due to a risk of valve leaflet damage during balloon dilatation procedures. This could lead to improper valve function and require additional medical intervention.
During a post-implant balloon dilatation procedure, the valve leaflets could become damaged, potentially leading to improper valve function. This might require additional medical intervention or surgery to correct the issue.
Patients who have received the Evolut PRO System heart valve implants with the listed model numbers are most at risk. Healthcare providers using these devices for procedures may also be affected.
Check the product label for model numbers EVOLUTPRO-23, EVOLUTPRO-26, or EVOLUTPRO-29 with specific suffixes like PRO COMM 29L, BLUE 6L, or BLUE COMM JPN. The recall includes devices sold in the US, Canada, Australia, and other regions.
Look for model numbers EVOLUTPRO-23, EVOLUTPRO-26, or EVOLUTPRO-29 with specific suffixes on the product label.
Reach out to Medtronic Heart Valves Division for further instructions on the recall and potential remedies.
The recall includes Evolut PRO System models EVOLUTPRO-23, EVOLUTPRO-26, and EVOLUTPRO-29 with specific suffixes like PRO COMM 29L, BLUE 6L, or BLUE COMM JPN.
The recall is due to a potential risk of valve leaflet damage during post-implant balloon dilatation procedures, which could affect heart valve function.
No, the recall does not require immediate discontinuation. Patients should contact Medtronic for specific guidance based on their device model.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0560-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0560-2021 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.
