FDA communications dated July 14 confirmed the second recall in a month for certain Impella products. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from the purge sidearm of the pump.
The latest medical device correction notice sent by Abiomed includes potential issues with six Impella models. It covers the Impella 2.5, Impella 5.0, Impella 5.5 with Smart Assist, Impella LD, Impella CP and Impella CP with Smart Assist. The issue relates to potential contact with transcatheter aortic valve replacement (TAVR) implants.
This marks the first communication regarding the issue in the U.S., as Abiomed already issued a warning in Europe. The product is not being removed from the field and does not need to be returned.
More about the latest Abiomed Impella recall
Abiomed warns of the potential risk of unintentional interaction of the Impella motor housing with the distal stent of a TAVR. The outflow struts of the TAVR can enter the outlet opening of Impella, damaging the spinning impeller during repositioning. That may fracture the impeller material. This could result in the destruction of impeller blades, potentially leading to low flow from a damaged Impella system.
The device correction notice states that Abiomed has not identified any events of this occurring. However, systemic embolization of the fractured impeller material remains a possibility. Abiomed received 27 complaints of this complication, representing 0.7% of patients with TAVR supported by Impella. The time period for this ranges from 2016 to present. Abiomed said 25 of the 27 complaints involved the Impella CP.
In TAVR patients who require hemodynamic support. clinicians should factor the risk into their risk-benefit analysis, Abiomed said. The company cautioned the clinicians to position the Impella system carefully. The risk of interaction increases for oversized or under-expanded frames with distal ends not flush with the aortic wall.
Abiomed intends to revise the instructions for use for the subject pumps to include the recommendations related to the potential issue.
Statement from Abiomed
A company spokesperson issued the following statement via email:
“At Abiomed, our first priority is our patients, including the safe and effective use of our products.
“On June 14, 2023, we issued a notification to customers regarding the safe use of left-sided Impella heart pumps in patients with a [TAVR] valve. The notification addresses the potential risk for unintentional interaction of the Impella motor housing with the distal stent of a previously implanted TAVR valve and provides further recommendations on how to position Impella in these patients.
“This notification was not a device removal. These devices remain available, and Impella technology can continue to be used safely in patients with a previously implanted TAVR valve.”
