Abbott/Thoratec Corp. Recalls HeartMate II And HeartMate 3 Left Ventricular Assist System Due To Long-term Buildup Causing An Obstruction
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Abbott/Thoratec Corp. is recalling HeartMate II and HeartMate 3 LVAS due to a risk of obstruction from biological material buildup, identified as a Class I recall by the FDA. This issue, occurring over two years or more, can lead to serious injuries or death, with 273 reported injuries and 14 deaths. Healthcare professionals and patients using these devices are affected. An Urgent Medical Device Correction Letter was sent to customers on February 19, 2024, advising on monitoring and addressing low flow alarms indicative of this obstruction.
April 15, 2024 | 3:26 pm
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Abbott Laboratories, in partnership with Thoratec Corp., is recalling its HeartMate II and HeartMate 3 LVAS due to a serious obstruction issue, leading to 273 injuries and 14 deaths. This Class I recall could impact Abbott's reputation and financials due to potential legal and healthcare costs.
The recall of HeartMate II and HeartMate 3 LVAS by Abbott due to serious health risks is a significant event that could lead to financial liabilities from lawsuits, increased regulatory scrutiny, and damage to the company's reputation in the medical device market. The direct association of Abbott with this recall, especially with the high number of reported injuries and deaths, makes it highly relevant and potentially impactful to Abbott's short-term stock performance. The negative sentiment surrounding a Class I recall, the most serious type, could lead to a decrease in investor confidence.
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