Medtronic recalls Evera ICD models with specific product numbers due to possible prevention of high and low voltage therapy. Affected devices may not treat life-threatening heart rhythms properly.
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Medtronic is recalling Evera ICD models that could prevent high and low voltage therapy, which is critical for treating life-threatening heart rhythms. This risk means the devices might not function correctly when needed.
The devices may fail to deliver necessary high or low voltage therapy during heart emergencies. This could prevent treatment of dangerous heart rhythms like ventricular fibrillation or tachycardia.
People with Medtronic Evera ICDs (implantable heart devices) who own the recalled models are affected. Those with heart conditions requiring these devices are most at risk.
Check your device's product number (e.g., DDBC3D1, DVBC3D1) and serial number (e.g., BWG204574H) on the device label. The recall includes specific Evera ICD models listed in the notice.
Look for the product number (e.g., DDBC3D1) and serial number (e.g., BWG204574H) on the device label.
The recall includes Evera S DR ICD DF1 (Product No. DDBC3D1), Evera S VR ICD DF1 (Product No. DVBC3D1), Evera S VR ICD DF4 (Product No. DVBC3D4), Evera XT DR ICD DF1 (Product No. DDBB1D1), Evera XT VR ICD DF1 (Product No. DVBB1D1), Evera XT VR ICD DF4 (Product No. DVBB1D4), and additional models with specific product numbers and serial numbers.
Check your device label for the product number (e.g., DDBC3D1) and serial number (e.g., BWG204574H). The recall lists specific product numbers and serial numbers for affected devices.
The recall does not specify a remedy, so contact Medtronic directly for guidance on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0587-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0587-2018 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.
