番茄社区

The labeling for several mechanical circulatory support devices is under a sweeping class I recall due to the risk of left ventricle perforations, the .

While not subject to a product removal, over 66,000 Impella left-sided blood pumps now have their instructions for use (IFU) under a "correction" recall.

Device maker Abiomed is taking this action because of the risk that the pump catheter may cut through the wall of the heart's left ventricle. Already, there have been 129 reported serious injuries, including 49 reports of death associated with the perforation issue.

On Dec. 27, 2023, Abiomed sent affected customers an Urgent Medical Device Correction letter with updated warnings that stress careful positioning of the Impella pump catheter under image guidance.

The affected models listed in the recall notice are the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD.

Impellas are used to temporarily reduce the work of the heart's ventricles and provide support for the circulatory system. Impellas may be used in a variety of settings, including percutaneous coronary intervention, cardiogenic shock, open-heart surgery, or cardiomyopathy.

Nearly 8,000 Impella devices were recalled in the summer of 2023 for potential interactions with transcatheter aortic valve replacement (TAVR) stents. Devices were not taken off the market, but the IFU amended to warn against motor damage that may occur if the Impella comes into contact with the distal stent of the TAVR system, which could lead to reduced blood flow or the pump stopping.

Around the same time, there was also a narrower class I recall of the labeling for because the catheters' IFU did not appropriately address precautions against blood clots.

Earlier that year, the had been subject to another class I recall due to complaints of purge fluid leaks that result in low purge pressures. Abiomed coordinated product returns related to that recall of under 500 devices.

Comment