– something that is not adequately addressed in the pumps’ current instructions for use (IFU).
This recall represents a “voluntary correction, not a product removal.” Impella heart pumps do not need to be returned, the U.S. Food and Drug Administration says.
Instead, the company will update the pump’s IFU to include guidance to clinicians on how to manage use of Impella in patients with TAVR.
Clinicians may continue to use the Impella devices, with the additional instructions for patients with TAVR in mind, the FDA says.
As explained in the recall notice, there is a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR, which may damage or destroy the motor’s impeller blades.
“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream,” the notice warns.
The recall covers 7895 devices distributed from May 1, 2021, to the present, including the following devices:
- Impella 5.0 Blood Pump, product number 005062
- Impella CP Blood Pump, product number 0048-0032
- Impella 2.5 Blood Pump, product number 005042
- Impella CP with SmartAssist Blood Pump, product numbers 0048-0024, 0048-0045, and 1000080
- Impella LD Blood Pump, product number 005082
- Impella 5.5 with SmartAssist Blood Pump, product numbers 0550-0008 and 1000100.
Abiomed reports 30 complaints, 26 injuries, and 4 deaths related to this issue, which has garnered a class I recall from the FDA, the most serious type.
In an urgent device correction letter sent to health care professionals in June, Abiomed says, “For a patient with TAVR who needs hemodynamic support, clinicians should factor this risk into the risk benefit analysis and are cautioned to position the Impella system carefully as directed in this notification.
“The risk of interaction is increased for oversized or under expanded frames with the distal ends not flush with the aortic wall, resulting in the distal stent structures oriented in such a way as to potentially enter the outflow window and allow contact of the end of the stent with the spinning impeller,” the letter states.
Clinicians are advised to avoid repositioning while the device is spinning and to turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity with the valve stent structures.
If low flow is observed in a patient implanted with a TAVR while on Impella heart pump support, clinicians should consider damage of the impeller and replace the Impella pump as soon as possible, the company says.
Questions about this recall can be addressed to Shashi Thoutam at 734-262-6255 and/or local clinical field staff.
Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.