Impella Heart Pump Recall Investigation
The Lyon Firm is investigating the recent Impella heart pump recall initiated by the FDA following reports of heart-wall tears, and an apparent increased risk of death. If you or a loved one have been injured by a recalled left-sided blood pump, contact a medical device defect lawyer to review your case. We offer free and confidential consultations.
What Happened with the Impella Heart Pumps?
The Food and Drug Administration (FDA) issued a Class I recall, its highest-level alert, after an investigation stemming from 2021 found a heart pump linked to reports of 49 deaths and dozens of patient injuries. The recall includes updated instructions from Impella, the device’s maker, to physicians on how they should use the medical device.
Impella heart pumps are typically used for the short-term support in pumping blood to the chambers of the heart’s ventricles during medical procedures, or following a severe heart attack. They are used during high-risk catheter-based procedures called percutaneous coronary interventions (PCI).
Percutaneous coronary intervention (PCI) is a treatment to open a blocked artery. Arteries are the blood vessels that carry oxygen-rich blood through your body. Patients may need a PCI if they have a buildup of plaque in the arteries or to clear blockages after a heart attack. Another name for a PCI is coronary angioplasty.
The Impella Left Sided Blood Pumps have been scrutinized because the pump catheter may perforate the wall of the left ventricle in the heart, which is obviously a medical event all doctors and patients would like to steer clear of. The FDA has warned of the perforation risk, and the device company has advised customers to review new instructions. The officials FDA statement explained:
“During operations, the Impella device could cut through the wall of the left ventricle. The use of the affected Impellla pumps may cause serious adverse health consequences, including left ventricle perforation of free wall rupture, hypertension, lack of blood flow, and death.”
Who is Impacted by the Impella Heart Pump Recall?
An investigation found the Impella pump may have been involved in 129 serious injuries and 49 reports of death. The blood pumps have been in use from October 2021 to October 2023. More than 66,000 devices were recalled in the U.S. after the FDA issued the urgent medical correction letter.
Any patient who has anterior infarction or undergoing procedures with Impella Left Sided Blood Pumps could be at risk. These safety concerns are thought to be a more recent problem at Abiomed, the parent company of the pumps.
The FDA first cleared the Impella heart pump for use in 2008. Around 300,000 Impella devices had been used in patients for more than a decade, and there were no reports of heart-wall perforations due to any known manufacturing errors. Now Abiomed has said they are working on broad improvements, and noted the heart-wall tears were a rare “known complication.”
Understanding the Timeline of Events
The Impella pump heart perforation risk was first revealed to physicians in a company bulletin posted in October 2021. However, the company did not share this critical information with the FDA at that time, allegedly violating FDA protocol. The bulletin said the heart pump’s “rare complication” was first noted in January 2018.
The FDA issued a warning letter to Abiomed in September 2023 after completing an investigation and citing the company’s failure to update the FDA about the risk of heart perforation that it had identified two years prior. Inspectors also found non-reported complaints about the devices.
As a result of the FDA scrutiny and subsequent warning, Abiomed issued an Urgent Medical Device Correction letter on December 27, requesting that customers adhere to new and revised heart pump warnings. These warnings to doctors included careful positioning of the pump during procedures, using imaging when advancing the pump and using special care when inserting the pump.
A study dating back to 2013 saw the potential for the heart pump to sever vessels and lead to serious bleeding. Other related studies found Impella heart devices increased the risk of death in patients with certain unstable medical conditions.
Which Impella Heart Pumps Were Recalled?
Abiomed is recalling its Impella Left Sided Blood Pumps because the pump catheter may cut the wall of the left ventricle in the heart during operation. Over 66,000 units were recalled on December 27, 2023, which include the following:
- Impella 2.5
- Impella CP
- Impella CP with SmartAssist
- Impella 5.0
- Impella 5.5 with SmartAssist
- Impella LD
On March 21, 2024, the FDA posted a completed summary on its website detailing the “most serious type of recall.” Even though the FDA referred to a recall, the device will remain on the market with updated instructions for use.
Johnson & Johnson MedTech acquired Abiomed in 2022. In a statement, J&J MedTech, called the deadly issue a “rare and known complication during invasive cardiology procedures,” and claimed actions have been taken to try to reduce future risk.
Why Hire The Lyon Firm?
Joe Lyon has 20 years of experience filing medical device recall and product liability lawsuits on behalf of plaintiffs in all fifty states. Following an injury or a wrongful death linked to a recalled heart pump or another medical device, individuals and families can consider taking legal action. Contact our medical device recall lawyers to learn more about the recent Impella heart pump recall, and to discuss the next steps.
We believe very strongly that any company that produces, markets and distributes a product as important as a medical device has a duty to properly test it before it is released to the public. The FDA has already determined that this company may have violated their policy of being transparent with complaints and discoveries of possible health risks related to their products. If such allegations ring true, and a death of a patient could have been prevented, a wrongful death lawsuit may be a viable option.
Call us now for a free case review, and to learn more about the process of filing a complaint. Following a device recall, there may be more reason to take legal action. The responsible company and safety agencies must have good reason to issue a serious warning about the safety of these heart pumps, and the Lyon Firm is urging impacted plaintiffs to come forward and potentially hold them accountable.