
In a significant development following a series of Class I recall labels issued earlier in the year due to safety concerns associated with Abiomed heart pumps, the FDA has escalated its regulatory action by issuing a warning letter to a company under the ownership of Johnson & Johnson. The recent release of this warning letter is part of a broader effort to address persistent issues concerning Impella heart pumps and the software used for monitoring these life-saving devices.
This latest action by the FDA is rooted in an extensive inspection of Abiomed’s facility located in Danvers, Massachusetts, which unfolded over several weeks during spring. The inspection uncovered a myriad of issues, raising serious concerns for the agency. In response to the findings, Abiomed made multiple attempts to address the FDA’s concerns, submitting four responses between May and September. However, the FDA deemed many of these responses “inadequate,” and in some instances, the adequacy of the responses could not be established to the agency’s satisfaction.
A central point of contention in the warning letter revolves around the FDA’s determination that Abiomed has been utilizing the Impella Connect system without the appropriate premarket approval or investigational device exemption. Abiomed argued that this system, designed to provide real-time information from an Impella controller to healthcare providers, does not require regulatory approval since it is not considered a medical device. According to the company, the software and remote link modules merely facilitate communication without affecting the pump’s core functionality.
In stark contrast, the FDA vehemently disagreed, asserting that the Impella Connect system serves as a “secondary alarm system.” It employs color coding to convey the severity of alarms raised by the automated pump controllers, thereby offering healthcare providers vital patient-specific medical information to identify life-threatening conditions and time-critical alarms.
The warning letter did not stop at the Impella Connect system. It went on to criticize Abiomed’s manufacturing practices, suggesting that the company failed to adequately address manufacturing flaws responsible for certain pump-related issues. Some of these problems escalated to the point of Class I recalls. Furthermore, the FDA accused Abiomed of not establishing a proper procedure for reviewing complaints received about its devices, some of which may have merited reporting to the regulator.
The FDA’s concerns extended to the classification of Abiomed’s Impella pumps as “misbranded.” This designation stemmed from alleged violations of FDA regulations regarding the timely reporting of serious injuries or deaths linked to a company’s device. Additionally, Abiomed was accused of submitting complaints late and missing the 10-day deadline for presenting plans to correct issues with Impella 5.5 pumps in 2020 and 2021.
In light of these serious allegations and concerns, the FDA has directed Abiomed to take swift and resolute action to rectify the violations outlined in the warning letter. The company has been given a 15-business day window to respond, providing details on the actions taken and those planned to address these issues and ensure the safety and efficacy of their heart pumps.
Abiomed, in response to the FDA’s warning letter, has expressed its commitment to working closely with the regulatory agency to promptly address the observations and concerns. The company has underlined its dedication to delivering safe and effective life-supporting heart pump technology to patients, assuring the public that Impella heart pumps will remain available on the market for those in need.