Abiomed devices manufactured by Johnson & Johnson face a recall following the deaths of three patients using their heart pumps.
In a significant development, the Food and Drug Administration (FDA) has announced a recall of automated controllers for Impella heart pumps manufactured by Johnson & Johnson's subsidiary, Abiomed. This recall, initially classified as a Class I recall - the most serious type - was triggered in April 2023 due to complaints that purge fluid had leaked from the purge sidearm of the pump.
The FDA considers this fault a potentially high-risk issue and released an early alert about it. The recall follows a series of regulatory actions by the FDA, which started in April 2023. 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.
The fault causes the controllers to fail to detect the heart pump when connected. As a result, no visual alarm is triggered, which can lead to inadequate hemodynamic support for patients. No deaths have been reported in the recent recall of Impella heart pump controllers. However, the recall is due to a fault linked to three reported deaths.
Healthcare professionals use the Impella pump 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 has advised users to check for freezing screens on their controllers during console-to-console transfers or the case start process. If the screen freezes for more than 20 seconds, users should immediately switch the pump to the previous console or a different console to restore support to the patient.
Abiomed recommends having a back-up controller available to mitigate the risks. Recall information can change frequently, so it's important to check the FDA's Medical Device Recalls database regularly for updates. To access this information, visit [www.fda.gov](http://www.fda.gov). Navigate to the "Medical Devices" section and search for "Recalls" or "Medical Device Recalls." Use "Abiomed heart pumps" or similar relevant terms in the search bar to find specific recalls.
For more detailed information, you can also check the Johnson & Johnson website or contact their customer service. As this story is categorized under Medical Devices, FDA, Recalls, and Cardiac, it underscores the importance of regular device checks and adherence to safety protocols in the medical field. This article has been updated to include a statement from Johnson & Johnson.
- The medtech industry, specifically Johnson & Johnson's subsidiary Abiomed, has announced a recall of automated controllers for Impella heart pumps due to leaked purge fluid.
- This recall, classified as a Class I recall, is a result of a series of regulatory actions by the FDA, following complaints about the device and a failure to seek FDA approval for integrated software.
- The fault in the controllers can cause them to fail to detect the heart pump when connected, potentially leading to inadequate hemodynamic support for patients.
- Healthcare professionals and patients are advised to check for freezing screens on controllers during use and to have a back-up controller available to mitigate risks.
- Detailed information about the recall can be found on the FDA's Medical Device Recalls database or the Johnson & Johnson website.
- This recall underscores the importance of regular device checks and adherence to safety protocols in the healthcare industry, particularly in the medical-conditions and therapies-and-treatments related to cardiac conditions.
- The finance and business aspects of the medtech industry are also impacted as the recall may lead to increased costs and potential damage to the company's reputation.
- News outlets across the healthcare, regulation, AI, and science sectors are reporting on this development, highlighting the need for vigilance and continued research to improve medical devices and patient care.
