The US Food and Drug Administration Issues Highest-Level Alert for Heart Pump
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Published: 1 hour ago
The US Food and Drug Administration (FDA) has recently raised serious concerns over a heart pump that has been associated with a concerning number of deaths and injuries. Impella left sided pumps, which are commonly used to provide temporary heart support during high-risk procedures or after a severe heart attack, have been linked to 49 deaths and 129 injuries.
Device Misuse and Potential Risks
The FDA highlights that the misuse of the Impella pumps can pose serious risks to patients. If used incorrectly, the pump may puncture the heart’s left ventricle, leading to potential life-threatening complications. The agency classifies this recall as the most serious type, emphasizing the potential for severe injuries or death if the device is not used as directed. Potential serious health consequences of using the affected pumps include hypertension, lack of blood flow, and death.
Manufacturer’s Response
The manufacturer of the device, Abiomed, has responded to this alert by issuing new instructions for the proper use of the heart pump. Johnson & Johnson, which acquired Abiomed in 2022, confirmed that the product remains on the market and continues to be available for patients.
Significant Recall
According to the FDA, the latest recall notice is related to approximately 66,390 devices that were distributed in the US between October 10, 2021, and now. Despite the recall, the FDA clarifies that this is a correction rather than a complete product removal, allowing the device to remain in the market.
Root of the Issue
The FDA inspected Abiomed’s office in Massachusetts early in 2023, prompting a subsequent warning letter in September addressing several concerns, including the failure to update the FDA on the risk of heart perforation associated with the device. Abiomed’s response to the warning letter involved issuing an “Urgent Medical Device Correction letter” at the end of last year. This letter contained revised instructions on the proper use of the heart pump, emphasizing the importance of correct placement of the pump’s catheter and employing imaging techniques during procedures.
In conclusion, the FDA’s issuance of its highest-level alert for the Impella left sided pumps sends a clear message about the significant risks associated with improper use of the device. Abiomed’s prompt action to provide revised instructions is aimed to mitigate the potential dangers to patients. The vigilance of regulatory authorities and active engagement by manufacturers will hopefully contribute to improved patient safety in the future.
