The U.S. Food and Drug Administration (FDA) has announced that Abiomed is recalling its instructions for certain Impella left-sided blood pumps due to significant safety concerns. New and revised instructions for use (IFU) have been sent to all affected customers.
This is a Class I recall, which means following the original instructions when using the Impella devices “may cause serious injuries or death.” To date, the issue has been associated with 129 serious injuries and 49 reports of death.
“Abiomed is recalling its Impella left-sided blood pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart,” according to the FDA advisory. “During operations, the Impella device could cut through the wall of the left ventricle. The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow and death.”
The recall includes 66,390 Impella devices distributed to customers from October 2021 to October 2023. Specific product names listed in the advisory include the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD heart pumps.
This recall is a correction, not a product removal
This Class I recall is technically a correction and not a full product removal. This means the devices included in the announcement can still be used to treat patients, according to the FDA—as long as clinicians refer to the new and revised warnings that were provided to customers along with an Urgent Medical Device Correction in December.
The updated warnings include the following recommendations:
- Carefully position the pump catheter during operative procedures
- Use imaging when advancing or torquing the pump catheter
- Use special care when inserting the pump catheter in patients with certain high risk conditions or during active CPR
- Review the updated warnings in the device IFU
- Notify everyone at your facility who needs to be informed of this recall correction
- Notify any other facilities where the products have been forwarded of the updated IFU
Click here to read the full advisory.
Abiomed comments on Impella recall
Abiomed sent a statement to Cardiovascular Business about the Class I recall.
“Abiomed has updated our IFU for our Impella system to further address the potential risk of a rare complication, left ventricular (LV) perforation,” the company said. “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. This notification is not a device removal and Impella heart pumps remain on the market and available for patients.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.