Abbott recall of LAAO catheters designated class I
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Key takeaways:
- Abbott recalled LAAO catheters distributed between Oct. 4, 2022, and Feb. 22, 2023 due to risk for air embolism.
- The FDA has identified the recall as class I, the most serious type.
Abbott announced a recall of its cardiac catheter used in procedures for left atrial appendage occlusion due to risk for air embolism, potentially causing stroke or death.
The FDA has identified the recall as class I, the most serious type of recall.
Image: Adobe Stock
Air embolism caused by the device (Amplatzer Steerable Delivery Sheath) can lead to STEMI, tachycardia or bradycardia, hypotension and oxygen desaturation, according to an alert from the FDA.
The recall includes 672 catheters distributed between Oct. 4, 2022 and Feb. 22, 2023.
The company reported 26 incidents, 16 injuries and no deaths related to this issue.
Abbott provided the following statement by email to Healio:
“Abbott has recalled one of the delivery systems used to implant the Amplatzer Amulet Left Atrial Appendage (LAA) Occluder after receiving a small number of reports of air entering the delivery system. The company has communicated this to physicians and regulatory bodies and is working with hospitals to return any unused Amplatzer Steerable Delivery Sheaths.
“Importantly, the recall of the delivery system does not impact the Amplatzer Amulet LAA Occluder device and physicians can continue to use the Amplatzer TorqVue 45°x45° Delivery Sheath for future procedures.”
Editor’s Note: This article was updated on July 28, 2023 to add the statement from Abbott.
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