On Nov. 4, the U.S. Food and Drug Administration issued a class I recall for Abbot's CentriMag Acute Circulatory Support System. Abbot initiated the recall in August "due to a calibration system error resulting from electromagnetic interference that may cause the pump to slow or stop, the console screen to blank, and various inaccurate alarms." According to the safety alert, "if the pump slows or stops, the patient is at risk of service adverse health consequences such as stroke, severe organ damage or death."

The recall is for products with lot numbers L05333-0001 – L06608-0024 with distribution dates from Nov. 22, 2017 to Aug. 6, 2019. Abbot sent a Medical Device Recall letter to their customers on Aug. 22 with recommendations and actions.

Read the full FDA safety alert.

Keywords: ACC Advocacy, Medical Device Recalls, United States Food and Drug Administration, Calibration, Cardiovascular System, Death, Stroke, Electromagnetic Phenomena

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