FDA ranks separate recalls from Abbott, Philips as Class I, its most serious

FDA
Abbott said all impacted CentriMag consoles have been replaced following reports of 44 injuries and one patient death. (FDA)

The FDA recently labeled two device recalls as Class I, the most serious, after they were launched by Philips and Abbott earlier this year—including the latter’s CentriMag cardiac support system for open-heart surgeries following the death of a patient. 

The ventricular assist system is designed to pump a patient’s blood for up to six hours during a procedure, or longer in patients suffering from heart failure. Abbott began recalling the device Aug. 22 after it became known that electromagnetic interference and calibration system errors can cause the heart pump to slow down or stop completely. 

Additionally, the interference could make the console screen go blank or trigger various inaccurate alarms, according to the FDA. At the time of the recall, 44 injuries had been reported and one patient death.

FREE DAILY NEWSLETTER

Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

An Abbott spokesperson told Reuters all impacted CentriMag consoles have since been replaced. In its August letter to clinicians (PDF), the company said that if an electromagnetic interference issue occurs, audible alarms would alert users to the issue, and that they should switch the pump to its backup system. 

The devicemaker also said it made changes in manufacturing to address the motor calibration process and that it would help clinicians update and recalibrate the affected motors in the field.

RELATED: FDA issues Class I recall for Abbott’s HeartMate 3 heart pump

Meanwhile, Philips Medical Systems (Cleveland) has recalled about 850 of its nuclear imaging Forte Gamma Camera systems in the U.S., due to the risks of the 660-pound detector coming loose from the gantry and potentially crushing, trapping or injuring the patient or operating clinicians.

No injuries had been reported when Philips Medical Systems began its recall, the FDA said, after the company sent letters Sept. 19 to customers telling them to discontinue use of the camera system until further notice. The recall also includes the Forte Jetstream and Diamond Select Forte models.

Suggested Articles

By employing heart rate signals, physical activity and sleep quality, common Fitbit trackers may be able to predict the spread of the flu.

Nanox has raised $26 million to help fuel the development and commercialization of its Star Trek-inspired digital X-ray bed.

Oncology is clearly a major medical and societal issue, but one that sees too much focus from biopharmas at the expense of other killers.