The FDA has taken significant steps in its response to safety concerns surrounding certain Abiomed heart pumps. Following several Class I recalls earlier this year, the agency issued a warning letter to Abiomed, a company owned by Johnson & Johnson, which has been made public. This action comes after an FDA inspection of Abiomed’s Danvers, Massachusetts facility, which raised multiple concerns.
One key point in the FDA’s letter is its determination that the Impella Connect system has been used without proper premarket approval or investigational device exemption. Abiomed argued that this system does not require regulatory approval as it is not a medical device. The FDA disagreed, emphasizing that the Impella Connect system serves as a secondary alarm system, providing critical patient-specific information and requiring premarket authorization.
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The FDA’s letter also raised issues related to the manufacturing practices of Abiomed, stating that the company failed to adequately address manufacturing flaws, leading to certain pump-related problems and recalls. It also accused the company of lacking a proper procedure for reviewing device-related complaints.
Additionally, the FDA asserted that Abiomed’s Impella pumps are “misbranded” due to violations of the agency’s rules regarding reporting of serious injuries or deaths related to the devices and updates on device corrections and removals. Abiomed was found to have submitted complaints late or failed to report all complaints related to device malfunctions.
The FDA has called on Abiomed to promptly address the identified violations and provide a response within 15 business days outlining the steps it plans to take to rectify these issues.
