Heartware recalls Medtronic HVAD Packaged Monitors (models 1500-1522) due to potential cable damage from misalignment when connecting to controller ports.
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 Packaged Monitors with specific model numbers because cable connections can cause damage to the controller ports when misaligned. This could lead to device malfunction or failure if the cables are not properly aligned.
The hazard occurs when power and data cables (AC Adapter, DC Adapter, and Battery cables) are inserted into the HVAD Controller ports. Misalignment of the cables can cause wear and damage to the controller ports, potentially leading to device malfunction.
Owners of Medtronic HVAD Packaged Monitors with model numbers listed in the recall (e.g., 1500, 1500AU) are affected. Patients using these devices are at risk if cables become misaligned during connection.
Check your Medtronic HVAD Packaged Monitor for model numbers starting with 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, or other listed models. The recall includes all lot codes for these products.
Identify your Medtronic HVAD Packaged Monitor model number to confirm if it is in the recall list.
The recall does not specify an immediate stop-use action. The hazard is low risk and involves potential cable damage from misalignment, not immediate danger.
The recall does not provide specific remedy steps. You should check the model numbers and contact Heartware for further instructions.
No, only specific model numbers listed in the recall are affected. Not all Medtronic HVAD devices are included.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1341-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1341-2021 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.
