Heart Pump Controllers Manufactured by J&J's Subsidiary, Abiomed, Recalled Following Three Fatal Incidents
Johnson & Johnson's subsidiary, Abiomed, has initiated a recall of automated controllers for its Impella heart pumps due to a fault linked to three reported deaths. This fault can cause the controllers to fail to detect a pump when connected, leading to potential inadequate hemodynamic support for patients and significant risk.
The recall, which began in April 2023 as a Class I recall (the most serious type), does not remove the product from the market. Controllers and Impella pumps remain available, but with advised mitigation steps for users. If the screen freezes for more than 20 seconds and does not advance after connecting the pump to the transferred console, users should immediately switch the pump to the previous console to restore support to the patient.
The current recall was triggered by complaints that purge fluid had leaked from the purge sidearm of the pump. During a console-to-console transfer, the controller can freeze on a screen that tells users to anticoagulate once the sheath is in place. If the screen freezes for more than 20 seconds after connecting the pump and does not progress to indicate "Detecting Impella," users should switch the pump to a different console.
No new facts were provided about the need for a backup controller or the likelihood of device failure. Abiomed has advised users on how to mitigate the risk associated with the recalled controllers, but no new facts were provided about the steps to do so.
The Food and Drug Administration (FDA) has yet to classify the current recall, but has published an early alert, which the agency reserves for potentially high-risk issues. The FDA released an early alert about the recall a week after Abiomed contacted customers.
The Impella pump is used by healthcare professionals to provide temporary full or partial heart support during certain procedures or when a person's heart needs time to recover from an acute condition. Abiomed provides an automated Impella controller with the heart pumps, which serves as the primary user control interface for Impella pumps.
It is important to note that since the acquisition by Johnson & Johnson in December 2022, this recall now involves a total of 46 products. This story was originally titled "Abiomed heart pump recall labeled Class I by FDA, no deaths reported."
In a statement, Johnson & Johnson expressed their commitment to patient safety and cooperation with the FDA to address this issue. They are working closely with healthcare providers to ensure the safe and effective use of the Impella system.
In a separate incident, Abiomed received a warning letter in September 2023 for failing to report quality problems with Impella and for not seeking FDA approval for software integrated with the device. Johnson & Johnson has not yet issued a statement regarding this matter.
- The Food and Drug Administration (FDA) has yet to classify the recent recall of Abiomed's automated Impella controllers, but has issued an early alert, indicating potential high-risk issues.
- The current recall, initiated due to a fault linked to three reported deaths, does not remove the product from the market, but advises mitigation steps for users.
- The recalled controllers are used with Impella heart pumps, which are temporarily used by healthcare professionals to support a patient's heart during certain procedures or acute conditions.
- Johnson & Johnson, through its subsidiary Abiomed, is working closely with healthcare providers to ensure the safe and effective use of the Impella system, expressing their commitment to patient safety and cooperation with the FDA.
- In a separate incident, Abiomed received a warning letter in September 2023 for failing to report quality problems with Impella and for not seeking FDA approval for software integrated with the device.
- Since the acquisition by Johnson & Johnson in December 2022, this recall now involves a total of 46 products associated with the Impella heart pumps and controllers.
