FDA Says Abbott Recalls Heartmate Touch Communication System For Unintentional Pump Start And Stop; Recalling Their Heartmate Touch System (Version 1.0.32) For Risk Of Unexpected Pump Stop Or Start; Identified Heartmate Touch Communication System Recall As Class I Recall And 8 Reported Injuries, No Reports Of Death
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The FDA has announced that Abbott is recalling its Heartmate Touch Communication System (version 1.0.32) due to the risk of the device unexpectedly starting or stopping. This recall has been classified as a Class I recall, indicating a situation where there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death. There have been 8 reported injuries associated with this issue, but no deaths have been reported.
March 11, 2024 | 7:49 pm
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Abbott is recalling its Heartmate Touch Communication System due to risks of unexpected starts or stops, with 8 reported injuries but no deaths. This recall is classified as Class I, indicating serious potential health consequences.
The recall of a medical device, especially one classified as Class I, can have significant negative implications for Abbott's reputation in the medical device market. The reported injuries could lead to legal challenges and financial liabilities. Although no deaths have been reported, the severity of the recall could lead to increased scrutiny from regulators and a potential short-term negative impact on Abbott's stock price due to concerns over future sales and potential legal liabilities.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90