Heartware recalls Medtronic HVAD Battery models 1650, 1650CA-CLIN, 1650DE due to potential cable damage to controller ports from 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 Battery models 1650, 1650CA-CLIN, and 1650DE because cable misalignment can damage the controller ports. This could lead to device malfunction or failure if the battery is used without proper connection.
The cables may become misaligned when inserted into the controller ports, causing damage. This could result in the battery not functioning properly or the device failing to communicate with the controller.
Patients with Medtronic HVAD battery implants who own the recalled models are affected. Those with the specific product numbers listed are most at risk.
Check for product numbers 1650, 1650CA-CLIN, or 1650DE on the battery. The recall applies to all lot codes of these models.
Identify the product number on the battery to confirm if it is one of the recalled models.
The recall affects Medtronic HVAD Battery models 1650, 1650CA-CLIN, and 1650DE.
Check the product number on the battery; if it is 1650, 1650CA-CLIN, or 1650DE, it is affected.
Contact Heartware directly for further instructions as the recall remedy is not specified.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1340-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1340-2021 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.
