Heartware recalls HVAD System Battery Charger AC Adapters with model numbers 1640 (all serials) due to risk of inserting 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 AC Adapters (model 1640) because users might mistakenly insert the charger into the HVAD Controller's power port. This could cause improper function or damage to the medical device. The recall affects all units with model number 1640, including specific serial numbers listed in the notice.
The charger adapter could be inserted into the HVAD Controller's power port by mistake, potentially causing improper function or damage to the medical device. This might lead to the system not working correctly, which could affect the patient's hemodynamic support.
Patients using the Heartware HVAD System with the recalled battery charger adapters are most at risk. The recall includes all units with model number 1640 and specific serial numbers listed in the notice.
Check for model number 1640 on the adapter. All units with this model number and specific serial numbers listed in the recall notice are affected. The recall includes many different serial numbers across various regions.
Look for model number 1640 on the adapter. If it matches, the unit is affected.
Reach out to Heartware directly for assistance with the recall process.
The recalled adapter has model number 1640.
Check for model number 1640 on the adapter. Affected units include specific serial numbers listed in the recall notice.
No, but you should check if your adapter is affected and 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-1428-2020 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1428-2020 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.
