Heartware recalls specific HVAD system models for updated cleaning instructions to avoid removing lubricant from power connector pins, which could cause power switching issues.
Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.
Heartware is recalling certain HVAD systems to update cleaning instructions for the controller adapters and battery. This prevents cleaning the power source connector pins, which could remove lubricant meant to protect against power switching problems.
Cleaning the power connector pins without proper lubricant could cause power switching issues. The lubricant is applied to prevent this, so improper cleaning might lead to malfunction.
Patients using Heartware HVAD systems with the listed model numbers are affected. Those who have the specific model numbers in the recall list are most at risk.
Check the model numbers on your Heartware HVAD system: 1440, 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US, 1440, 1650, 1650CA-CLIN, 1650DE.
Identify your Heartware HVAD system's model number from the list provided in the recall notice.
No, the recall is for updated cleaning instructions only. You can continue using your system as normal.
Follow the updated cleaning instructions for the controller adapters and battery to avoid removing lubricant from the power connector pins.
The recall addresses a potential power switching issue, but it is not a risk of serious injury in normal use. The hazard is low risk.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0726-2022 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0726-2022 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.
