Heartware Medtronic HVAD System for cardiac patients with controller kits and adapters may experience brief electrical interruptions causing beeping. Affected units have specific product numbers and serials. Contact Heartware for details.
Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.
Heartware's Medtronic HVAD System for heart failure patients has a recall due to possible brief electrical interruptions between the power source and controller, which can cause beeping. This issue is caused by oxidation in the connectors and typically lasts 1-2 seconds.
The hazard occurs when oxidation builds up between the power source connector and socket, causing brief interruptions in the electrical connection. This can lead to unintended switching to a secondary power source or unexpected beeping sounds, but typically lasts only 1-2 seconds.
Patients using the Heartware Medtronic HVAD System for cardiac failure are affected. Those with the specific product numbers and serials listed in the recall are most at risk.
Check if your Heartware Medtronic HVAD System includes the listed controller kits, DC adapters, AC adapters, or battery packs with the specific product numbers and serials provided in the recall notice.
Review your Heartware Medtronic HVAD System's product numbers and serials against the list provided in the recall notice.
The recall is due to oxidation between power source connectors and sockets causing brief electrical interruptions that may lead to unintended switching to a secondary power source or unexpected beeping sounds.
Check your product numbers and serials against the specific lists provided in the recall notice for controller kits, DC adapters, AC adapters, and battery packs.
The recall notice does not specify a remedy, so contact Heartware directly for further instructions.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1903-2018 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1903-2018 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.
