Johnson & Johnson MedTech’s Abiomed division has another serious recall on its hands stemming from its line of miniaturized Impella heart pumps, following reports that the devices could pierce and cut through the wall of the left ventricle during operation.
The FDA reported this week that it was aware of 49 patient deaths related to the issue, among 129 records of severe injuries.
J&J’s Abiomed previously notified healthcare providers of the risks with an urgent medical device correction letter late in December, connected to more than 66,000 of the company’s various Impella pump models designed for use within the left side of the heart. The FDA handed the correction a Class I label March 20, the agency’s most serious recall designation—however, no device parts are being considered faulty, nor do they need to be returned to the manufacturer.
Instead, the company and the agency have updated the warnings to surgeons within the device’s instructions for use, or IFU, to underline the potential risk of perforation “due to operator handling,” according to the FDA’s recall posting.
“With patient safety top of mind, our IFU has been updated with stronger technical guidance around implantation and repositioning and emphasizes specific cardiac and peripheral vascular anatomic considerations when implanting Impella,” J&J MedTech said in a statement to Fierce Medtech. “This notification is not a device removal and Impella heart pumps remain on the market and available for patients.”
In addition, the FDA urged users to employ imaging when advancing or twisting the pump catheter and said people with specific risks may include women, the elderly and people with previous anterior infarctions—or scarred cardiac tissue located closest to the front of the chest following a heart attack. The agency also said special care should be used when delivering CPR chest compressions to an implanted patient.
Snaked into the heart’s chambers through the blood vessels, the less invasive pumps house an internal, spinning impeller to force blood out into the aorta to take some of the workload off a weakened cardiac muscle.
Last year, Abiomed received a Class I recall label for some of its left-side Impella models after more than two dozen cases of the impeller’s spinning blades colliding with previously implanted aortic heart valves, causing parts of the pump to fracture. The company urged surgeons to make sure the device was stopped before adjusting its position within the heart. The FDA later reported four deaths linked to the issue.
2023 also saw a Class I designation for one of the company’s right-sided pumps, the Impella RP Flex with SmartAssist, following an instruction update clarifying situations where a patient’s anticoagulation clotting time is less than recommended. Those patients may be at risk of blood clot formation or particle deposit buildups; the FDA reported 12 injuries linked to that recall.