FDA Says Abbott Recalls Heartmate 3 Left Ventricular Assist System Implant Kit For Risk Of Blood Leakage; Has Identified Heartmate 3 Left Ventricular Assist System Implant Kit As A Class I Recall; Abbott Reports 81 Incidents, Including 70 Injuries And Two Deaths Related To Issue
Portfolio Pulse from Benzinga Newsdesk
The FDA has announced that Abbott is recalling its Heartmate 3 Left Ventricular Assist System Implant Kit due to a risk of blood leakage. The recall has been classified as Class I, the most serious type. Abbott has reported 81 incidents, including 70 injuries and two deaths related to the issue.
May 15, 2024 | 3:13 pm
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Abbott is recalling its Heartmate 3 Left Ventricular Assist System Implant Kit due to a risk of blood leakage. The FDA has classified this as a Class I recall, the most serious type. Abbott has reported 81 incidents, including 70 injuries and two deaths related to the issue.
The recall of a medical device due to serious safety concerns, including injuries and deaths, is likely to negatively impact Abbott's stock price in the short term. The classification as a Class I recall by the FDA underscores the severity of the issue.
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