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.
This recall is a voluntary correction, not a product removal.
Recalled Product
- Product Names and Product Codes:
- 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, 1000080
- Impella LD Blood Pump, Product Number 005082
- Impella 5.5 with SmartAssist Blood Pump, Product Numbers 0550-0008 And 1000100
- Distribution Dates: May 1, 2021 to present
- Devices Recalled in the U.S.: 7,895
- Date Initiated by Firm: June 14, 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.
Reason for Recall
Abiomed is recalling the Impella Left Sided Blood Pumps because the pumps’ Instructions for Use (IFU) do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement (TAVR). The IFU lacks guidance to clinicians on how to manage use of Impella in patients with TAVR and fails to describe how the issue may present if an Impella interacts with TAVR. There is a potential risk that the Impella motor housing may come into contact with the distal stent of a transcatheter aortic valve replacement (TAVR). The contact 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.
Use of affected devices may cause serious injury or death.
Abiomed reports 30 complaints, 26 injuries, and four deaths related to this issue.
Please note that clinicians may continue to use the devices, with the additional instructions for patients with TAVR in mind.
Who May be Affected
- People who receive ventricle and circulatory support from Impella Left Sided Blood Pumps.
- Health care personnel providing care for people who receive support using the Impella Left Sided Blood Pumps.
