Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor
Damage After Contact with Transcatheter Aortic Valve Replacement
(TAVR) Stent
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.
Please be aware, 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
(https://medlineplus.gov/ency/article/000185.htm) 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 (https://medlineplus.gov/cardiomyopathy.html). 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.
Contact Information
Customers with questions about this recall should contact Shashi Thoutam at +1(734) 262-6255 and/or their local
clinical field staff.
Additional Resources
Medical Device Recall Database entry: Impella 5.0 Intravascular Micro Axial Blood Pump
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=200240)
Medical Device Recall Database entry: Impella CP Intravascular Micro Axial Blood Pump
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=200243)
Medical Device Recall Database entry: Impella 2.5 Intravascular Micro Axial Blood Pump 005042
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=200239)
Medical Device Recall Database entry: Impella CP with SmartAssist Intravascular Micro Axial Blood Pump
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=200244)
Medical Device Recall Database entry: Impella LD Intravascular Micro Axial Blood Pump
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=200241)
Medical Device Recall Database entry: Impella 5.5 with SmartAssist Intravascular Micro Axial Blood Pump
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=200242)
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) they experienced using these
devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form,
regular mail, or FAX.