FDA Expands Recall of Impella Heart Pump Controllers After 3 Deaths
The FDA has expanded its recall of certain Impella heart pump controllers due to purge flag failures that can delay support, with 37 serious injuries and three deaths reported.
4 reports on this incident · first at Aug 27, 2026, 10:00 p.m. ET
Earlier reports
Aug 27, 2026, 10:09 p.m. ET
FDA Reports 37 Injuries, 3 Deaths in Ongoing Impella Controller Issue
The U.S. Food and Drug Administration (FDA) has received reports of 37 serious injuries and three deaths associated with purge flag failures in certain Impella heart pump controllers, according to a report from Medical Daily. The agency's report, dated August 26, 2026, describes an ongoing issue that began with an alert on August 12, 2026.
The affected devices are the Automated Impella Controller, Impella Optical Controller, and Optical AIC Impella Controller in their US packaged configurations, made by Abiomed. The FDA states that a failure before support begins can delay the procedure, and in a patient who is already hemodynamically unstable, that delay can mean a prolonged stretch without mechanical circulatory support.
The agency's recommended remedy is to reinsert the purge disc; if the alarm does not clear, switch to a backup controller. The cause of the failures has not been determined, and the FDA has not stated a definitive cause.
Aug 27, 2026, 10:04 p.m. ET
FDA Closes Recall of Impella Controllers Linked to 3 Deaths
The U.S. Food and Drug Administration has closed the recall of certain Impella heart pump controllers, according to a report from Medical Daily. The agency considers the recall carried out, meaning it has been completed to the FDA's satisfaction.
The recall, initiated on August 12, 2026, covers the Automated Impella Controller, Impella Optical Controller, and Optical AIC Impella Controller in their US packaged configurations. The action was prompted by purge flag failures inside the purge pressure sensor assembly, which can delay the start of circulatory support in hemodynamically unstable patients. The FDA reported 37 serious injuries and three deaths associated with the issue.
For anyone still using the affected controllers, the remedy is to reinsert the purge disc; if the alarm does not clear, switch to a backup controller. The recall status remains ongoing, according to the report.
Aug 27, 2026, 10:00 p.m. ETFirst report
FDA Warns of Impella Controller Failures Linked to 3 Deaths
The U.S. Food and Drug Administration (FDA) has issued a safety alert about certain Impella heart pump controllers, reporting 37 serious injuries and three deaths, according to medicaldaily.com. The alert, initiated on August 12, 2026, and reported on August 26, 2026, covers the Automated Impella Controller, Impella Optical Controller, and Optical AIC Impella Controller in their U.S. packaged configurations.
The hazard involves purge flag failures inside the purge pressure sensor assembly. A failure before support begins can delay the procedure, and in a patient who is already hemodynamically unstable, that delay can mean a prolonged stretch without mechanical circulatory support, the report said.
The FDA recommends that users reinsert the purge disc, and if the alarm does not clear, switch to a backup controller. The status of the alert is ongoing, according to medicaldaily.com.
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