Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bubble Sensor (REF: 70105.5720) Recalled by Maquet Medical Systems USA Due to The Bubble Sensor optional accessory to the CARDIOHELP-i...
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 Medical Systems USA directly.
Affected Products
Bubble Sensor (REF: 70105.5720)
Quantity: 274 units (70 US, 204 OUS)
Why Was This Recalled?
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
Where Was This Sold?
This product was distributed to 13 states: AZ, CA, CO, FL, GA, IL, IA, MN, NE, PA, TX, WA, WI
About Maquet Medical Systems USA
Maquet Medical Systems USA has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report