Heartware recalls Medtronic HVAD Controller models 1400-1407 with potential port damage from cable misalignment. Affected users should contact Heartware for details.
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
Heartware is recalling Medtronic HVAD Controllers with specific product numbers due to a risk that cables can damage the controller ports when inserted incorrectly. This could lead to device malfunction or failure if the cables are misaligned.
The hazard occurs when power cables, alarm adapters, or monitor data cables are inserted into the controller ports with misalignment. This wear and tear can damage the ports, potentially causing device malfunction or failure.
Patients using Medtronic HVAD devices with the recalled product numbers are most at risk. The recall affects individuals who have the specific model numbers listed in the notice.
Check your Medtronic HVAD Controller for product numbers starting with 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, or similar numbers listed in the recall notice.
Identify your Medtronic HVAD Controller's product number to see if it matches the recalled list.
The recall does not require immediate stop use; however, you should check if your device is affected and contact Heartware for guidance.
Heartware will provide instructions for affected users, but the recall record does not specify a remedy.
Check the product number on your device against the list of recalled numbers provided in the recall notice.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1336-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1336-2021 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.
