Dive Brief:
- Abiomed’s Impella heart pumps can potentially interact with transcatheter aortic valve replacement (TAVR) stents, causing damage to the heart pump’s motor, the Food and Drug Administration said in a recall posted Friday.
- The company, which was acquired by Johnson & Johnson in December, began the recall of its Impella heart pumps in June, warning that the problem could result in low flow from the damaged pump or that the fractured material could block blood flow.
- Abiomed is not pulling the device from the market, but cautioned physicians to place it carefully in patients.
Dive Insight:
The FDA marked the recall as Class I, its highest risk category. It did not specify whether any injuries or deaths had been reported.
The recall includes Abiomed’s Impella CP with SmartAssist, Impella 5.5, Impella 5.0, Impella 2.5 and Impella LD pumps, totaling 9,252 units.
The devices are used to support the heart’s pumping chambers after a heart attack or heart surgery, or because of a condition called cardiomyopathy. There’s a risk that the Impella motor housing could interact with the distal stent of a TAVR implant, destroying the heart pump’s blades, according to the FDA’s notice.
Abiomed said physicians should be aware of this potential interaction when they’re placing the device, and avoid repositioning it while the device is spinning. If low flow is observed in a patient that has a TAVR implant, clinicians should consider damage of the impeller and replace the pump as soon as possible.
Abiomed’s Impella was recalled again earlier this year for a problem with fluid leaking from the purge sidearm of the pump. The device has also faced scrutiny after a study last year found a high mortality rate for patients who were not part of the initial approval group, leading Abiomed to narrow the label for the device to be used 48 hours after patients develop heart failure.