Heartware recalls HVAD System Batteries (Product Number 1650DE) due to battery performance issues that may cause failure to power the controller or accept charge. Affected units have specific serial numbers and GTIN.
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
Heartware is recalling HVAD System Batteries with Product Number 1650DE because they may not power the device's controller or accept charge properly. This could lead to the battery appearing charged while actually discharging. Affected units have specific serial numbers and GTIN.
The batteries may fail to power the device's controller or accept charge from the charger. This could cause the battery to appear charged while actually discharging, potentially leading to system failure.
Patients using Heartware HVAD systems with the recalled battery model (Product Number 1650DE) are most at risk. The recall affects specific serial numbers and GTIN.
Check if your HVAD system battery has Product Number 1650DE. Look for the GTIN 00763000187767 or the listed serial numbers in the recall notice.
Identify your battery's serial number to see if it's listed in the recall (e.g., BAT941874, BAT941880, etc.).
Reach out to Heartware directly for assistance with the recall process.
The product number for the recalled batteries is 1650DE.
Check the serial number on your battery against the list of affected serial numbers provided in the recall notice.
The recall does not specify an immediate replacement deadline; contact Heartware for guidance.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1512-2022 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1512-2022 from Heartware. 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.
