Heartware recalls HVAD System Battery Charger models with potential for incorrect AC adapter insertion into HVAD Controller power port. Affected units include specific model numbers and serials listed in the recall notice.
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Heartware is recalling its HVAD System Battery Charger due to a risk of mistakenly inserting the AC adapter into the HVAD Controller's power port. This could cause improper operation of the life-support device. The recall affects specific model numbers and serial numbers listed in the notice.
The charger's AC adapter could be inserted into the HVAD Controller's power port by mistake, leading to improper operation of the life-support device. This might cause the system to malfunction or fail to function correctly.
Patients using the Heartware HVAD System with the recalled battery charger are at risk. The recall includes specific model numbers and serial numbers listed in the notice.
Check for model numbers starting with 1610 and serial numbers listed in the recall notice. The affected units include specific combinations of model numbers and serial numbers provided in the official recall list.
Identify your charger's model number (starts with 1610) and serial number to see if it's listed in the recall notice.
If your charger is affected, contact Heartware directly for instructions on how to proceed with the recall.
The recall is for a potential risk of incorrect port insertion, which could lead to improper operation of the life-support device. It is not immediately dangerous but requires attention.
Check your charger's model number (starts with 1610) and serial number against the list of affected units provided in the recall notice.
Contact Heartware directly for instructions on how to proceed with the recall. The recall does not include a specific remedy for replacement or repair.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1427-2020 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1427-2020 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.
