Hot on the heels of handing down a trio of Class I recall labels this year to safety events concerning certain Abiomed heart pumps, the FDA has gone a step further in its crackdown.
The agency issued a warning letter to the Johnson & Johnson-owned company last month—and made it public this week—to highlight lingering issues it’s detected among the Impella pumps and their associated device-monitoring software.
The letter comes after an FDA inspection of Abiomed’s Danvers, Massachusetts, facility that spanned several weeks in the spring and sparked a host of concerns from the agency, which Abiomed attempted to address in four responses sent between May and September, to no avail: The FDA deemed many of the responses “not adequate,” while the adequacy of others “cannot be determined at this time.”
Leading the letter is the FDA’s determination that the Impella Connect system is being used without a proper premarket approval or investigational device exemption. In its response, per the letter, Abiomed argued that the system doesn’t need regulatory approval because it’s not a medical device, since its software and remote link modules are only used to provide healthcare providers with real-time information gathered from an Impella controller but can’t affect the actual function of the pump.
“We disagree,” the FDA replied, saying that the Impella Connect system actually acts as “a secondary alarm system” by color-coding its display based on the severity of alarms raised by the automated pump controllers.
Those color-coded tiles “provide patient-specific medical information to detect a life-threatening condition and display time-critical alarms intended to notify a health-care provider, which are functions that meet the definition of a device under the [Federal Food, Drug and Cosmetic Act] and therefore require premarket authorization,” the agency wrote.
Elsewhere in the letter, the FDA raised several more issues related to the pumps themselves.
One set of complaints concerned Abiomed’s manufacturing practices, asserting that the devicemaker had failed to properly correct the manufacturing flaws behind certain issues with the pumps—including some that went on to escalate into Class I recalls—and to validate the corrective actions it did take. The FDA also accused the company of having failed to establish and maintain a proper procedure for reviewing complaints it receives about its devices, some of which may need to be passed on to the regulator.
Finally, the letter asserted that Abiomed’s Impella pumps are “misbranded” due to violations of the FDA’s rules around passing along to the agency in a timely manner any reports of serious injury or death linked to a company’s device and any updates surrounding device corrections and removals. With respect to the former, the FDA said Abiomed had either submitted complaints late or not passed along all complaints received relating to certain device malfunctions; in the latter case, the FDA said Abiomed missed the 10-day deadline to submit its plans to correct Impella 5.5 pumps in 2020 and 2021.
The agency advised Abiomed to “take prompt action to address any violations identified in this letter” and gave it 15 business days to issue a response detailing the steps it has already taken and still plans to take to correct the outlined issues.
In a statement sent to Fierce Medtech, Abiomed said, “We are working closely with the FDA to fully resolve the observations as quickly as possible. As we continue to integrate into Johnson & Johnson MedTech, we are implementing quality system process improvements related to the observations, and many of these corrective actions are already in process.”
The statement continued, “We are dedicated to the mission of providing safe and effective life supporting heart pump technology to patients worldwide, and Impella heart pumps remain on the market and available for patients in need.”