ClickCease
logo
GET STARTEDlinecall443-731-0267
What are you looking for?

FDA Inspection of Impella Device 

  • January 27, 2025
  • KBA Attorneys
  • No Comments

FDA Inspection of Impella Device 

FDA conducted an inspection of Abiomed’s facility in Danvers, Massachusetts in the Spring of 2023. Following the inspection, FDA issued a warning letter to Abiomed on September 19, 2023. The warning letter followed a back-and-forth between FDA and Abiomed regarding several issues related to the Impella line of products that FDA found during its inspection.

The letter can be found here:

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abiomed-inc-663150-09192023

The letter outlines several areas in which Abiomed failed to meet FDA guidelines and regulations with regard to the Impella products.

 

FDA First Determination: Selling and Promoting Impella’s Connect System

First, FDA determined that Abiomed was selling and promoting a component for the Impella device that FDA had not approved. The component is called the Impella Connect System, which includes software and hardware that allow healthcare professionals to monitor the Impella’s performance, and, critically, to receive instant alerts if there are any safety issues while the device is being used. FDA had not approved either the software nor the hardware, and FDA rejected Abiomed’s assertions that the Impella Connect System did not require FDA approval. FDA found that both “provide patient-specific medical information to detect a life-threatening condition and generate time-critical alarms intended to notify a health-care provider.” Because of that serious, and potentially life-saving purpose, FDA requires that the Impella Connect System has FDA approval.

 

The Abiomed FDA warning letter was a significant step, and, as reported, was consistent with FDA beginning to closely monitor software tools and monitors.

 

FDA Second Determination: Lack of Internal Quality Control Procedures

Second, FDA determined that Abiomed had failed to follow several of its own internal quality-control procedures. This lead to faulty components being produced, which in turn led to devices that could leak or malfunction. FDA notes in the letter that several complaints had been received. It documents instances in which the Impella device leaks, and even stopped working, while implanted in a patient. This is known as a purge sidearm leak, and it can lead to the device stopping therapy, which for patients in a critical condition, can be a life-threatening complication. Abiodmed recalled certain Impella units for leak issues in April 2023.

 

FDA Third Determination: Delayed Reporting of Medical Device Reports

Third, FDA determined that Abiomed had delayed reporting what are called Medical Device Reports, or MDRs, to FDA. Abiomed is required to file an MDR with FDA within 30 days of it becoming aware that one of its products may have caused or contributed to a death or serious injury. FDA found several instances in which Abiomed was made aware that an Impella device may have contributed to a serious injury but after which Abiomed did not timely submit an MDR to FDA.

 

As an example, the letter notes that on December 14, 2020, Abiomed was made aware that an Impella device stopped working while implanted in a patient, and that the Impella could not be restarted because of a “broken purge side arm.”: Rather than report the event to FDA, Abiomed decided the malfunction was due to the user and Abiomed did not report it. Later, on March 9, 2023, Abiomed changed course and reported the event, but this was well after the 30-day deadline.

 

Abiomed did something similar, according to the warning letter, with several malfunction reports. Abiomed initially blamed something other than the Impella, then decided to report the event to FDA on March 9, 2023. FDA noted an extensive review process, undertaken by Abiomed, of prior malfunction reports, and that Abiomed failed to provide FDA with any documentation related to that process.


FDA Final Determination: Failed to Report “Technical Bulletins” to FDA First

Finally, FDA noted that Abiomed sent numerous “Technical Bulletins” to doctors and healthcare providers that it did not first send to FDA. These Bulletins were related to serious, life-threatening issues with the Impella products. One involved a purge/leak issue that could result in the device stopping while in use, which could lead to heart failure and death. Another Bulletin involved instances in which the Impella device perforated, or punctured, the wall of the heart. A puncture of the heart is a life-threatening condition that can result in a massive bleed within the heart chamber. Abiomed presumably, and according to the warning letter, did not notify FDA of the perforation issue. Rather, Abiomed chose to issue a “Technical Bulletin” in which it characterized the issue as a “risk of operator mishandling,” or, that the doctor using the device is not using it correctly.

 

Abiomed issued the perforation Technical Bulletin in October 2021. However, the issue was continuing to happen. It led to a class 1 FDA recall of the instructions for the Abiomed in December 2023. That recall is below:

 

https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks

 

Overall, FDA’s letter to Abiomed is extensive. It references a consistent pattern of non-compliance with several issues spanning 4-5 years. FDA also took the somewhat unusual step of publishing the letter, further highlighting FDA’s presumed frustration with Abiomed and Abiomed’s manufacturing and monitoring of the Impella product line.

 

KBA Attorneys is Investigating The Impella Device 

KBA Attorneys is actively investigating the risks associated with Impella Left-Sided Blood Pumps, including the serious complications highlighted in the FDA’s recent warnings and recalls. It is sad to see these critical heart supporting devices failing due to a lack of warnings. 

The life-threatening issues associated with these devices such as ventricular perforation, device leakage, pump stoppages, and insufficient blood flow. These issues have resulted in numerous injuries and deaths are a horrific tragedy. 

The many reports that show incidents of purge system leaks, heart wall tears, hypertension, and even fatalities due to pump malfunctions should not be as high as they are. 

Johnson & Johnson acquired Abiomed in November of 2022. Any Impella litigation could involve J&J. Our attorneys have extensive experience litigating cases against J&J. Notably, Robert Price has experience litigating both pelvic mesh and hernia mesh cases against Ethicon, a company that is owned by J&J.

 

KBA Attorneys Helping Heart Device Failure Victims

Our law firm has and will continue to stand up for individuals who are affected by the Impella devices. We have written about this topic many times over the years to help spread the word about its dangers. 

The Impella Device – The Impella Heart Pump

Implanted with an Impella Heart Pump? 

The Abiomed Impella Device Lawsuit

Increased Mortality Rates and the Abiomed Impella RP System

 

Our law firm has experience handling failed medical device cases, especially heart devices. Aside from the Impella device, KBA Attorneys has litigated defibtech RMU, Heartmate. More information on those particular devices are below. 

The RMU medical device – Defibtech’s RMU Recall

FDA Recall of the HeartMate 3™

More News about the HeartMate II and HeartMate 3 Recalls

Latest Abbott HeartMate System Recall and What It Means for Patients

HeartMate System Monitor Recall

 

If you or someone you know has experienced a failure of a heart device or any other medical devices, contact us today! Our team is here to help you understand your rights and hold those responsible accountable.