HeartMate 3 System Controller membrane may lift, risking fluid damage and device failure
Thoratec LLC is recalling 694 HeartMate 3 System Controllers because the UI membrane may lift along the housing, allowing fluid entry that could damage internal circuits and cause loss of power or pump failure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall affecting a life-critical left ventricular assist system controller. Although no reported illnesses or deaths are mentioned in the source, the hazard (fluid ingress causing circuit board damage) poses serious risk of harm, including loss of power and pump failure on a cardiac support device.
Plain-English summary
Thoratec LLC is recalling specific HeartMate 3 System Controllers used within left ventricular assist systems. The affected controllers include models 106524US, 106524INT, 106531US, 106531INT, and 106531LF2, totaling 694 units distributed throughout the United States and internationally. Specific affected serial numbers are documented by the FDA.
The UI membrane or screen on these controllers may lift along the edge of the housing. If the controller becomes exposed to fluid, water or other liquids may enter the device, potentially damaging the printed circuit board assemblies inside.
Fluid damage to the circuit boards could result in serious device failures: unexpected or false positive alarms, loss of visual alarms, loss of user interface functions such as button operation, loss of electrical power to the device, or failure of the pump to continue operating. These failures could prevent proper monitoring and function of the life-support system.
The recalled product
- Product
- HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System
- Manufacturer
- Thoratec LLC
- Affected units
- 694
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- HSC-134392
- HSC-134393
- HSC-134394
- HSC-134395
- HSC-134396
- HSC-134397
- HSC-134398
- HSC-134399
- HSC-134400
- HSC-134401
- HSC-134402
- HSC-134403
- HSC-134404
- HSC-134405
- HSC-134406
- HSC-134407
- HSC-134408
- HSC-134409
- HSC-134410
- HSC-134411
Distribution
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