Epoch HealthFDA Announces Recall of Heart Device Warning of ‘Serious Injuries or Death’

The FDA recalls Abbott’s HeartMate 3 system after reports of blood leakage and air entry during implantation, highlighting broader implications for device integrity and patient safety.

The US Food and Drug Administration (FDA) has issued a recall for Abbott’s HeartMate 3 left ventricular assist device (LVAD) following reports of two deaths and 70 injuries. This marks the second recall for the HeartMate 3 system due to serious complications observed during device implantation, including blood leakage and air entrapment, which can lead to severe surgical and postoperative complications.

Key Points:

• FDA Recall: The FDA announced a recall for Abbott’s HeartMate 3 LVAD after two deaths and 70 injuries were reported, due to serious complications observed during device implantation.
• Previous Recall: This is the second recall for the HeartMate 3 system, with a prior recall for the HeartMate Touch System.
• Reason for Recall: The recall was initiated after identifying blood leakage or air entering the seal interface between the LVAD inflow cannula and the apical cuff during implantation.
• Potential Complications: These issues can compromise blood flow integrity, potentially leading to extended surgery times, bleeding (hemorrhage), right heart failure, or air embolism.
• Incident Reports: Abbott reported two deaths, 70 injuries, and 81 incidents linked to the device, emphasizing the potential for serious injury or death.
• Notification and Recommendations: In March, Abbott issued a notification letter recommending adherence to standard surgical procedures and providing guidance on managing blood leaks and air entrapment.
• Surgical Management: Recommendations include adjusting pump position, allowing natural coagulation, reversing anticoagulation, adding surgical materials, or replacing the apical cuff and/or pump.
• Other Recalls: The FDA also recalled Philips Respironics’ Trilogy ventilators due to software issues causing power malfunctions, and the 2.7 version of the Apple iOS t:connect mobile app for the t:slim X2 insulin pump due to risks of pump shutdown leading to potential hyperglycemia or diabetic ketoacidosis.
• Implications for Practice: Physicians must stay informed about device recalls and follow manufacturer guidelines and FDA recommendations to mitigate risks associated with these medical devices.

“In all reported events, the issue was observed during implantation of the device. Blood leakage or air entering the LVAD from this location will impact the integrity of the blood flow and may lead to longer than expected surgery, bleeding (hemorrhage), right heart failure, or air embolism.”

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