Thoratec recalls HeartMate 3 System Controllers with specific model numbers and serials due to risk of fluid exposure causing false alarms and system failure. Affected units include certain HeartMate 3 LVAS Implant Kits and controllers.
Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop
Thoratec is recalling specific HeartMate 3 System Controllers and LVAS Implant Kits that may lift along the edge of the controller housing. If exposed to fluid, this could damage internal components and cause false alarms, loss of power, or pump stoppage. This is a serious issue for patients using these life-support devices.
The controller's UI membrane/screen may lift along the housing edge. If exposed to fluid, this can cause internal damage to printed circuit boards, leading to false alarms, loss of visual alerts, button functionality, power loss, or pump shutdown.
Patients using HeartMate 3 Left Ventricular Assist Systems (LVAS) with the recalled controllers or implant kits are most at risk. The recall affects specific model numbers and serial numbers listed in the notice.
Check for the following model numbers: 106524US, 106524INT, 106531US, 106531INT, 106531LF2. Also look for the specific serial numbers listed in the recall notice, which include HSC-134168 and other HSC codes.
Identify your HeartMate 3 System Controller model number (e.g., 106531US) and serial number (e.g., HSC-134168) to determine if it's affected.
Reach out to Thoratec directly for assistance with the recall process and to confirm if your device is affected.
If exposed to fluid, the controller's internal components may be damaged, causing false alarms, loss of visual alerts, button functionality, power loss, or pump shutdown.
Check your controller's model number and serial number against the list provided in the recall notice, which includes specific model numbers like 106531US and serials like HSC-134168.
Contact Thoratec directly to confirm if your device is affected and follow their instructions for the next steps.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-2583-2024 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-2583-2024 from Thoratec. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
