The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death
Abiomed recalls the instructions for use for Impella left sided blood pumps due to perforation risks. (Credit: Robina Weermeijer on Unsplash)
Recalled Product
US Available Product Names: Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist ; Impella LD
Distribution Dates: October 10, 2021 to October 10, 2023
Devices Recalled in the U.S.: 66,390
Date Initiated by Firm: December 27, 2023
Device Use
Impella Left Sided Blood Pumps are used for short term support of the pumping chambers of the heart (ventricles) during high-risk catheter-based procedures called percutaneous coronary interventions (PCI). Impella Left Sided Blood Pumps also are used when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack (acute myocardial infarction), open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy. Impella therapy aims to reduce the work of the heart’s ventricles and provide support for the circulatory system so the heart has time to recover. There are several types of Impella pumps that are used for different therapeutic reasons.
Reason for Recall
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. 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.
There have been 129 reported serious injuries, including 49 reports of death.
Who May be Affected
People who are undergoing procedures with the Impella Left Sided Blood Pumps
People who have anterior infarction (heart disease)
Elderly people and women
What to Do
On December 27, 2023, Abiomed sent all affected customers an Urgent Medical Device Correction letter.
The letter requested customers to adhere to new and revised warnings:
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 Instructions for Use
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 Instructions for Use
Source: Company Press Release