Medtronic recalls HeartWare Battery Model 1650DE (serial numbers listed) due to weld defect causing battery malfunction. No power or improper charging may occur.
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.
Medtronic is recalling HeartWare Battery Model 1650DE components because they have a weld defect that can cause the battery to malfunction. This means the battery may not hold a full charge or properly recharge, potentially affecting the heart assist device it powers.
The battery has a weld defect that affects internal components, causing it to malfunction. This can result in the battery not providing power or failing to hold a complete charge or recharge properly.
Patients using the HeartWare Ventricular Assist Device (HVAD) system with the recalled battery model are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check if your HeartWare Ventricular Assist Device (HVAD) system includes the HeartWare Battery Model #1650DE with the serial numbers listed in the recall notice. The batteries have an expiration date of April 30, 2022.
Look for the serial number on the battery to confirm if it's in the list of affected units provided in the recall notice.
No, the recall does not require immediate discontinuation of use. However, you should check if your battery is affected and take action if it is.
The battery may not provide power or hold a complete charge, which could affect the function of the HeartWare Ventricular Assist Device.
Check the serial number against the list of affected units provided in the recall notice. The affected batteries have an expiration date of April 30, 2022.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1266-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1266-2022 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.
