Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HLS Set Advanced Model Name: BEQ-HLS 5050 USA Recalled by Maquet Cardiovascular Us Sales, Llc Due to The HLS Set Advanced (disposable for Cardiohelp) is...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Cardiovascular Us Sales, Llc directly.
Affected Products
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
Quantity: 58,438 devices worldwide
Why Was This Recalled?
The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Cardiovascular Us Sales, Llc
Maquet Cardiovascular Us Sales, Llc has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report