Medtronic recalls CoreValve Evolut PRO PLUS Delivery Catheter Systems made 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 CoreValve Evolut PRO PLUS Delivery Catheter Systems manufactured before July 11, 2020 because reports indicate these devices can separate internally. This separation could lead to device failure during medical procedures, potentially causing harm to patients.
The actuator in the delivery catheter system can separate during use, which may cause the device to malfunction. This malfunction could lead to improper deployment of the heart valve, potentially causing complications for the patient.
Patients undergoing heart valve procedures who have the recalled catheter system are most at risk. Medical professionals using the device for treatments may also be affected.
Check for model numbers D-EVPROP2329US or D-EVPROP34US with specific lot numbers listed in the recall notice. The product was manufactured before July 11, 2020.
Identify the model number and lot numbers to confirm if your device is affected by this recall.
Reach out to Medtronic Heart Valves Division for guidance on next steps if your device is affected.
The actuator in the delivery catheter system can separate, which may cause device malfunction during medical procedures.
The affected products were manufactured before July 11, 2020.
Check the model number (D-EVPROP2329US or D-EVPROP34US) and lot numbers listed in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2043-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2043-2021 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.
