Maquet recalls QUADROX-i Adult Oxygenators due to potential packaging pinholes that could allow non-sterile exposure, risking infection during surgery. Affected units have specific model numbers and serial codes.
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Maquet is recalling QUADROX-i Adult Oxygenators used in heart surgery because their packaging might have tiny pinholes that aren't visible to the naked eye. This could let non-sterile materials get inside, causing infections or other serious health issues during surgery.
The oxygenator packaging may have small pinholes that aren't visible without help. If these pinholes let non-sterile materials get inside, it could cause infections, inflammation, sepsis, or tissue damage during surgery.
Healthcare professionals using the QUADROX-i Oxygenators during cardiopulmonary bypass procedures are most at risk. Patients undergoing heart surgery with this device could face infections or complications.
Check for model numbers HMO 70000-USA (701067820), HMO 71000-USA (701067823), or BEQ-HMO 71000-USA (701067829) on the packaging. All lots of these models are affected.
Inspect the packaging for small pinholes that may not be visible to the naked eye.
The packaging may have small pinholes that aren't visible to the naked eye, which could allow non-sterile materials to enter the oxygenator, risking infections or other complications during surgery.
Affected models include HMO 70000-USA (701067820), HMO 71000-USA (701067823), and BEQ-HMO 71000-USA (701067829).
No immediate stop is required, but you should check the packaging for pinholes and contact Maquet if you have concerns.
We’ve drafted a message you can send Maquet Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1659-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1659-2023 from Maquet Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
