Medtronic recalls CoreValve Evolut R Delivery Catheter Systems made before July 11, 2020 due to reported actuator separation. Affected models include ENVEOR-L and ENVEOR-N with specific lot numbers.
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Medtronic is recalling CoreValve Evolut R Delivery Catheter Systems made before July 11, 2020 because reports indicate actuator separation. This could lead to device failure during medical procedures.
The actuator separation hazard means the delivery catheter could malfunction during heart valve implantation procedures. This could cause improper valve placement or device failure, potentially leading to complications for the patient.
Patients receiving heart valve procedures using the recalled catheter systems are affected. Medical professionals using these devices for implantation are at risk of device failure.
Check for model numbers ENVEOR-L or ENVEOR-N on the catheter packaging. The products were manufactured before July 11, 2020 and include specific lot numbers listed in the recall notice.
Identify the model number (ENVEOR-L or ENVEOR-N) and lot numbers from the recall list to confirm if your device is affected.
The recall reports actuator separation for these delivery catheter systems, which could cause device failure during heart valve implantation procedures.
The affected models are ENVEOR-L and ENVEOR-N with specific lot numbers listed in the recall notice.
The affected products were manufactured before July 11, 2020.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2041-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2041-2021 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.
