Dive Brief:
- Johnson & Johnson’s Abiomed has recalled automated controllers for its Impella heart pumps over a fault linked to three deaths, the Food and Drug Administration said last week.
- Abiomed’s controllers can fail to detect a pump when connected. No visual alarm is triggered by the fault, which can lead to inadequate hemodynamic support that puts patients at risk.
- The FDA released an early alert about a week after Abiomed contacted customers because the fault is a potentially high-risk issue. Abiomed has advised users on how to mitigate the risk.
Dive Insight:
Healthcare professionals use the Impella pump to provide temporary full or partial heart support. The device pumps part or all of the patient’s blood circulation 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. The device is the primary user control interface for Impella pumps. Information about the use of the pump, including error messages when needed, are shown on the controller’s screen.
The company has identified two situations in which the controller may fail to detect the Impella pump when connected. During a console-to-console transfer, the controller can freeze on a screen that tells users to anticoagulate once the sheath is in place.
Abiomed has asked users to check if the screen freezes for more than 20 seconds and does not advance after connecting the pump to the transferred console. If that happens, users should immediately switch the pump to the previous console to restore support to the patient. Abiomed has advised users to switch to a different console if the previous console displays an alarm message.
The other fault happens during the case start process, when the screen can freeze on information about connecting up the controller. Abiomed has asked users to switch the pump to a different console if the screen freezes for more than 20 seconds after connecting the pump and does not progress to indicate “Detecting Impella.”
To mitigate the risks, the company has told users to have a back-up controller available. Abiomed said device failure is unlikely. The FDA is yet to classify the recall but has published an early alert, which the agency reserves for potentially high-risk issues.
When FDA classifies the recall, the affected controllers will add to the list of 46 products that Abiomed has recalled since being acquired by J&J in December 2022.
The run of post-takeover regulatory actions began in April 2023 with a Class I recall that was triggered by complaints that purge fluid had leaked from the purge sidearm of the pump.
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.
