Medtronic recalls CoreValve Evolut PRO Delivery Catheter Systems (manufactured before July 11, 2020) due to reported actuator separation. Affected units include specific model numbers and lot numbers listed in the recall notice.
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Medtronic is recalling certain CoreValve Evolut PRO Delivery Catheter Systems made before July 11, 2020 because of reports of actuator separation. This could lead to improper function of the device during medical procedures.
The actuator separation issue can cause the delivery catheter system to malfunction during heart valve procedures. This may lead to improper deployment of the heart valve device, potentially causing complications for the patient.
Patients who have received the recalled catheter systems for heart valve procedures are most at risk. Healthcare providers using these devices for medical treatments may also be affected.
Check for model numbers ENVPRO-14, ENVPRO-16, or ENVPRO-16-C with specific lot numbers listed in the recall notice. Products manufactured before July 11, 2020 are affected.
Identify your catheter system model and lot numbers to determine if it is affected by this recall.
Reach out to Medtronic directly for guidance on next steps if your product is affected.
Medtronic is recalling CoreValve Evolut PRO Delivery Catheter Systems manufactured before July 11, 2020 due to reports of actuator separation.
Check your model number and lot numbers against the list provided in the recall notice. Affected products include specific model numbers and lot numbers listed in the record.
Contact Medtronic directly for guidance on next steps. The recall does not specify a replacement or repair process.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2042-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2042-2021 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.
