FDA Issues Early Alerts for Heart Pump, Blood Glucose Monitor, and Homecare Bed Safety Issues

The FDA has issued early alerts for three separate medical device safety issues involving heart pump components, blood glucose monitors, and homecare beds, affecting thousands of patients and healthcare facilities across the United States.

Abiomed sent a letter to affected customers on February 18, 2026, recommending removal of Generation 1 Purge Cassettes used with Impella heart pumps due to an increased risk of purge leaks. The affected devices include Impella RP US Pump Set (Product Code 004334) and Purge Cassette 5 Pack (Product Code 0043-0003). A purge leak may lead to low purge pressure if it goes unaddressed, which can lead to biomaterial ingress and may result in an unexpected pump stop. A pump stop may result in a loss of hemodynamic support and lead to patient death. As of February 3, Abiomed has reported four serious injuries and no deaths associated with this issue. The purge cassette delivers rinsing fluid to the Impella catheter, with purge fluid flowing through the catheter to the microaxial blood pump to prevent blood from entering the motor.

Trividia Health issued an urgent medical device correction on February 6, 2026, for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO Self-Monitoring and TRUE METRIX PRO Professional Monitoring Blood Glucose Systems. The company is correcting the E-5 Error Code instructions in the Owner's Booklets and online labeling. The system displays an E-5 error code for a very high blood glucose event (greater than 600 mg/dL) or when there is a test strip error. As currently written, the instructions could potentially lead to a delay in treatment if the user does not seek medical attention immediately when they receive an E-5 error code and are experiencing symptoms of high glucose. A delay in treatment may result in serious adverse health consequences, such as dehydration, altered mental status, or death, especially for users with very high blood glucose levels. As of January 16, Trividia Health has reported 114 serious injuries and one death associated with this issue.

Medline Industries sent a letter to affected customers on November 26 regarding updated instructions for use for Medline Basic Beds and Medlite Homecare Beds. Medline has identified electrical safety risks with its Medline Basic Homecare Beds that may lead to fire. The electrical safety risk involves the hand control pendant and associated wires for Medline Basic Homecare Beds. In certain scenarios—such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor—the hand pendant and pendant cords may overheat and, in some instances, pose a risk of fire. Medline Industries has received reports of pendants sparking, burning, melting, smoking, and catching on fire. As of December 18, Medline has reported 12 injuries and one death associated with the electrical safety issue.

Additionally, Medline has identified patient entrapment as a potential issue when using non-Medline accessories on Medline beds. Non-Medline accessories or a user error when handling the pendant can unintentionally cause the bed to adjust position, entrapping the user's body between the bed and the accessory. Entrapment could lead to asphyxiation, serious injury, and death. Patients with reduced monitoring, such as those at home, are at increased risk due to delays in detecting and responding to entrapment incidents. As of December 18, Medline has reported two injuries and one death associated with the use of non-Medline approved accessories.

The FDA is recommending affected Medline beds be left unplugged from wall power unless adjustments that require electricity need to be made. For the Abiomed devices, if a Generation 2 Purge Cassette is not available and the use of a Generation 1 Purge Cassette is absolutely necessary, users should ensure increased monitoring of the Purge System. For the Trividia devices, if users receive an E-5 error code and are experiencing symptoms of high glucose, they should seek medical attention immediately.