Johnson & Johnson Issues Class I Recall and Updates Labeling for Impella RP and Impella RP Flex Cardiac Support Systems

Feb 15, 2025 10:30 CST Updated 10:30

Johnson & Johnson

Medical Device R&D and Manufacturer

FDA Issues Class I Recall for Johnson & Johnson's Cardiac Intervention Products: Impella RP (SmartAssist) and Impella RP Flex (SmartAssistant)The product is used for patients with acute right heart failure after the implantation of a left ventricular assist device (LVAD) and can be used for up to 14 days. Inserted through the internal jugular vein, the pump delivers blood to the pulmonary artery to support right heart function.

This recall event is mainly related to Johnson & JohnsonImpella RP（SmartAssist) and Impella RP Flex (SmartAssistant) TwoThe product's instruction manual, wherein the recall action does not involve removing the product from the point of use or sale.FDA categorized this recall as the most serious Class I recall, warning that if customers continue to use the device without following the updated operating instructions, it may lead to serious injury or death.

Reason for Updating the Instructions

During the placement, adjustment, or removal of a guidewire or other medical device, the tip of the Impella RP (SmartAssist) and Impella RP Flex (SmartAssist) may come into contact with the Impella pump body, posing a risk of damaging the optical sensor, causing the pump to pause or permanently shut down. Such failures may trigger alarms and result in the loss of some cardiac and blood pressure monitoring data.

Impella RP Flex (SmartAssistant) is used for patients with acute right heart failure after left ventricular assist device (LVAD) implantation and can be used for up to 14 days. Inserted through the internal jugular vein, the pump delivers blood to the pulmonary artery to support right heart function.

Johnson & Johnson Statement

"We have not found any manufacturing or design issues, nor have there been reports of patient injuries related to damage to the optical sensor."Please note that this recall is not a product removal, and Impella remains available for patient use.Educating healthcare professionals about the recommended practices to improve patient outcomes remains a priority, and we remain committed to providing safe and effective life-support heart pump technology to patients worldwide.”

As of now, notReceived &Reports of injuries or deaths related to this issue.This is ImpellaAnother Recall Incident of the Product Series---Another version last year was scrapped due to causing129 people were seriously injured (including 49 deaths)Recalled, and the RP model involved this time had also experienced a Class I recall in 2023.

Abiomed, acquired by Johnson & Johnson for $16.6 billion in 2022, has now become a cash cow for the company. In 2024, Abiomed generated $1.496 billion for Johnson & Johnson, representing a 14.5% year-over-year increase. The continued strong adoption of Impella 5.5 and Impella RP drove robust growth across all major commercial regions in the fourth quarter of last year.

Last OctoberJohnson & JohnsonImPELL Product Enters China's Medical Device Innovation Channel, in the Next Few YearsImPELL is expected to be listed in China again, bringing opportunities to the domestic market.Cardiogenic shock, left ventricular unloading (in conjunction with ECOM), high-risk PCI treatment, ventricular tachycardia ablation, and right ventricular failure bring new therapeutic technologies to patients.