Left ventricular assist system implant kit recalled for potential inflow cannula seal leak
Thoratec HeartMate 3 left ventricular assist system implant kits may develop a leak at the seal interface between the inflow cannula and titanium apical cuff, potentially compromising device function.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I classification indicates potential serious risk of adverse health consequences. The seal defect at the cannula-cuff interface could compromise function of a critical life-support device.
Plain-English summary
Thoratec Corp. is recalling the HeartMate 3 left ventricular assist system (LVAS) implant kit. This is an implantable device used in heart failure patients.
The recall was issued due to a potential leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. Such a leak could affect device function.
A total of 882 units were distributed worldwide, including throughout the United States and to numerous countries. The affected implant kits are identified by UDI 00813024013297 and specific serial numbers beginning with MLP-.
Patients with these implants should contact their healthcare provider. Physicians should evaluate the status of affected devices and take appropriate clinical action based on individual patient assessment.
The recalled product
- Product
- Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
- Manufacturer
- Thoratec Corp.
- Hazard
- device-failure
- seal-defect
Distribution
Distributed nationwide across the United States.
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