FDA Confirms Class I Recall of Johnson & Johnson Heart Device Over Connectivity Risk and Recent Deaths

The U.S. Food and Drug Administration has confirmed a new Class I recall involving Johnson & Johnson MedTech’s Automated Impella Controllers after identifying safety concerns related to potential connectivity failures.

The FDA has now determined that the issue meets the criteria for a Class I recall, the agency’s most serious category. A Class I designation indicates that continued use of the device without following the revised instructions could result in serious injury or death.

The recall stems from reports that the Automated Impella Controller may fail to detect when an Impella heart pump is connected. If the loss of connection is not recognized promptly, patients may receive inadequate hemodynamic support. The FDA noted that patients experiencing cardiogenic shock are especially vulnerable, as even short periods without sufficient support can be poorly tolerated and may lead to life-threatening outcomes.

The agency reported that the connectivity issue has been associated with three patient deaths.

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