The CentriMag System pumps blood through a patient for up to six
hours during open heart procedures and is also used to provide
temporary blood circulatory support to patients for up to 30 days.
The system includes a console that controls the pump speed and flow.
Abbott initiated the recall due to an error resulting from
electromagnetic interference that could cause the pump to slow or
stop, according to the FDA.
Slowing of the pump could put patients at the risk of stroke, severe
organ damage or death.
Forty-four injuries and one death were reported at the time when
Abbott started the recall in August this year, the FDA said on
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Abbott said it had issued a letter in August to inform hospitals
about the potential electromagnetic interference disrupting device
"All impacted CentriMag consoles were replaced," the company told
The FDA uses the term "recall" when a manufacturer takes corrective
action or removes a problematic medical device from the market. A
recall does not always mean that customers must stop using the
product or return it to the company.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shounak
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