FDA hands Class I label to Abbott’s Amplatzer sheath recall due to air embolism risk

FDA hands Class I label to Abbott’s Amplatzer sheath recall due to air embolism risk

The FDA has issued its most serious label to an Abbott recall of delivery catheters used for a specific minimally invasive heart surgery, due to a risk of introducing dangerous air bubbles into the bloodstream.

According to the agency, the steerable delivery sheath used to insert the company’s Amplatzer Amulet implant through the skin has the potential to create an air embolism—which, as it travels through the vessels to different organs, can cause sudden reductions in blood flow to the heart or consequences as serious as stroke and death.

Abbott has reported 26 incidents to the FDA, including 16 injuries and zero deaths. The company first issued its recall in mid-June, asking healthcare providers to return unused delivery systems. In its notice (PDF), Abbott said the overall incidence rate amounted to 0.77%.

The Amplatzer Amulet is used in left atrial appendage occlusion procedures, where an umbrella-like implant is snaked through the blood vessels into the heart and placed within a small pocket in the cardiac wall. This seals off an area where blood can pool and form clots; closing it can help lower a patient’s long-term chances of stroke, especially those with a higher risk due to an abnormal heart rhythm.

The recall, now designated Class I by the FDA, is specific to the delivery sheath and its hemostasis valve—spanning more than 670 devices distributed from October 2022 to February of this year—and does not impact the Amplatzer Amulet occluder implant itself.

Abbott said it would seek FDA approval for a new, modified replacement product. Until then, the company directed surgeons to instead use the fixed curve TorqVue 45°x45° delivery system for Amplatzer Amulet procedures.

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