FDA classifies Abbott's blood pumping system recall as most serious
The U.S. Food and Drug Administration on Monday classified the recall of Abbott Laboratories’ CentriMag blood pumping system following the death of a patient, as Class 1 or the most serious type of recall, Reuters reported.
The CentriMag System
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 Monday.
Abbott said it had issued a letter in August to inform hospitals about the potential electromagnetic interference disrupting device operation.
“All impacted CentriMag consoles were replaced,” the company told Reuters.
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.