Impella Heart Pumps: Risks and Complications

While designed to assist the heart’s ventricles and reduce workload, Impella Heart Pumps have unfortunately been associated with significant risks. Reports indicate at least 49 deaths and numerous serious injuries, with complications such as perforation of the heart’s left ventricle.

FDA Warning and Abiomed Recall

In response to these concerning reports, Abiomed initiated recalls of several Impella device models, prompted by the FDA’s issuance of a Class I Recall—the most serious type of warning for medical devices. This recall underscores the severity of the risks associated with Impella Heart Pumps.

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Legal Investigations and Potential Litigation

Legal teams are actively investigating these cases to determine liability and pursue justice for those affected by Impella Heart Pump complications. If you or a loved one has suffered injuries or fatalities related to these devices, you may be eligible to file a claim.

Recalled Impella Devices

Among the devices subject to recall are the:

  • Impella 2.5
  • Impella CP
  • Impella CP with SmartAssist
  • Impella 5.5 with SmartAssist
  • Impella LD

Regulatory Actions and Safety Concerns

Abiomed’s Impella Heart Pumps have faced regulatory scrutiny and operational challenges. Multiple recalls were issued in 2023, with the FDA issuing warnings regarding quality problems and failure to report adverse events.

Recent Developments and Patient Safety

In March 2024, Abiomed recalled over 66,000 Impella Left Sided Blood Pumps distributed between October 2021 and October 2023. This recall addresses the serious risk of left ventricle perforation, a condition associated with fatalities and injuries.

Enhanced Patient Safety Measures

Following the recall, Abiomed has taken steps to improve patient safety by updating instructions and communications regarding Impella Heart Pump usage.

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Contact Heninger Garrison Davis for Legal Assistance

If you or a family member have been affected by complications related to Abiomed Impella Heart Pumps, don’t hesitate to reach out to our legal team for a free consultation. We are committed to advocating for the rights of those harmed by these medical devices.

Contact Taylor Bartlett

[email protected]

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