Abiomed devices, manufactured by J&J, recall heart pumps controllers following three reported patient deaths
In a recent development, the Food and Drug Administration (FDA) has announced a recall of automated controllers for Impella heart pumps manufactured by Johnson & Johnson's (J&J) subsidiary, Abiomed. However, it is important to clarify that this recall does not involve the removal of the controllers or the Impella pumps from the market.
The recall is prompted by a fault in the controllers that can fail to detect a connected Impella pump, potentially leading to inadequate hemodynamic support for patients. Abiomed has identified two situations where the controller may fail to detect the Impella pump: during a console-to-console transfer and during the case start process.
In the event of a frozen screen during a console-to-console transfer, users are advised to immediately switch the pump to the previous console. During the case start process, if the screen freezes after connecting the pump and does not progress to indicate "Detecting Impella," users should switch the pump to a different console.
To mitigate the risks associated with this issue, Abiomed advises users to have a backup controller available. It is worth noting that as of my knowledge cutoff in December 2023, there have been no deaths reported in relation to the current recall of the automated controllers for Impella heart pumps.
This recall adds to the list of 46 products that Abiomed has recalled since being acquired by J&J in December 2022, once the FDA classifies the recall. The FDA has published an early alert about this issue, which is considered a potentially high-risk matter.
In September 2023, Abiomed received a warning letter from the FDA for failing to report quality problems with Impella and for not seeking FDA approval for software integrated with the device. This incident marked the beginning of a run of post-takeover regulatory actions, which included a Class I recall triggered by complaints that purge fluid had leaked from the purge sidearm of the pump in April 2023.
For the most current recall information, check the FDA Medical Device Recalls Database and search for “Abiomed” or “Impella.” Visit Abiomed’s news page and J&J’s product recall page for updates from the companies.
Johnson & Johnson states that the recall is not a product removal, and controllers and Impella pumps will remain on the market. Health professionals are advised to monitor FDA and manufacturer updates for new information.
This article was written by Peter Green and was updated on June 5, 2023. The article is related to Medical Devices, the FDA, Recalls, and Cardiac issues.
- The Food and Drug Administration (FDA) has announced a recall of automated controllers for Impella heart pumps manufactured by Johnson & Johnson's (J&J) subsidiary, Abiomed, due to a fault that can cause the controller to fail to detect a connected Impella pump.
- Abiomed has identified two situations where the controller may fail to detect the Impella pump: during a console-to-console transfer and during the case start process.
- To mitigate the risks associated with this issue, Abiomed advises users to have a backup controller available and to switch the pump to a different console in the mentioned situations.
- This recall adds to the list of 46 products that Abiomed has recalled since being acquired by J&J in December 2022, once the FDA classifies the recall.
- The FDA has published an early alert about this issue, which is considered a potentially high-risk matter. In September 2023, Abiomed received a warning letter from the FDA for failing to report quality problems with Impella and for not seeking FDA approval for software integrated with the device.
- Health professionals are advised to monitor FDA and manufacturer updates for new information, and for the most current recall information, they can check the FDA Medical Device Recalls Database and search for “Abiomed” or “Impella.”
