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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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.
- Affected units
- 882
Distribution
Part of a larger recall action
This product is one of 2 recalled by Thoratec Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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