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.
- 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
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.
What to Do
On June 14, 2023, Abiomed sent an Urgent Medical Device Correction notice to customers. The notice included the following recommended actions:
Actions for clinicians
- Be aware of this potential interaction between the Impella system and TAVR.
- Position the Impella system carefully in patients with TAVR.
- Avoid repositioning while the device is spinning.
- Turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity to the valve stent structures.
- If there is low flow observed in a patient implanted with a TAVR while on Impella heart pump support:
- Consider damage of the impeller as a possible cause.
- Replace the Impella pump as soon as possible.
Actions for customers
- Note that product is NOT being removed from the field and does not need to be returned.
- Review, complete all fields, sign, and return the business response form to the recall coordinator identified in the notice.
- Forward the notice to anyone in the facility who needs to be informed, including people who manage, transport, store, stock, or use the subject products.
- If any of the subject products have been forwarded to another facility, contact that facility and provide them with the notice.
- Post a copy of the notice in a visible area for awareness.
Customers with questions about this recall should contact Shashi Thoutam at +1(734) 262-6255 and/or their local clinical field staff.
- Medical Device Recall Database entry: Impella 5.0 Intravascular Micro Axial Blood Pump
- Medical Device Recall Database entry: Impella CP Intravascular Micro Axial Blood Pump
- Medical Device Recall Database entry: Impella 2.5 Intravascular Micro Axial Blood Pump 005042
- Medical Device Recall Database entry: Impella CP with SmartAssist Intravascular Micro Axial Blood Pump
- Medical Device Recall Database entry: Impella LD Intravascular Micro Axial Blood Pump
- Medical Device Recall Database entry: Impella 5.5 with SmartAssist Intravascular Micro Axial Blood Pump
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.