ZOLL Resuscitation Devices Recalled Nationwide Over Risk of CPR Failure

A major recall of life-saving medical equipment is now underway across the United States, as ZOLL Circulation, Inc. urges immediate discontinuation of its AutoPulse NXT Resuscitation System due to a critical malfunction. This recall, deemed the most serious classification by the U.S. Food and Drug Administration (FDA), involves the risk of the device delivering insufficient chest compressions—or stopping them entirely—during cardiopulmonary resuscitation (CPR), a failure that could lead to serious injury or death.

The affected devices are part of the AutoPulse NXT Platform, Model 200, running software version 2.0.1 with catalog number 8700-001070-1. According to the manufacturer, an internal fault code (FC1060) may result in incorrect compression depth detection. This error can interrupt CPR or render it ineffective by not providing enough pressure to maintain blood flow, increasing the risk of severe outcomes such as brain damage from oxygen deprivation.

ZOLL began notifying customers on March 4, 2025, instructing them to immediately stop using any of the identified units. The company is providing temporary replacement devices and requesting the return of the malfunctioning platforms. Repaired units will undergo a replacement of the defective center pulley assembly followed by final functionality testing.

While no injuries or fatalities have yet been reported, the recall affects a product commonly used in emergencies where every second counts. The AutoPulse NXT is designed for adult patients in cardiac arrest and is typically used by first responders and in hospitals to automate chest compressions. The FDA warns that continued use of the affected devices poses a significant danger, underscoring the urgency of following the recall procedures.

Healthcare providers and consumers with questions are directed to contact ZOLL Circulation at 408-541-2140. Those who believe they have experienced problems related to the device are encouraged to report incidents to the FDA through its MedWatch program to ensure continued safety oversight.

Article by multiple contributors, based upon information from ZOLL Circulation, Inc. and the U.S. Food and Drug Administration.

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