QUADROX-i Adult Oxygenator Recalled for Packaging Defects Compromising Sterility
Maquet is recalling QUADROX-i Adult Oxygenators used in cardiopulmonary bypass surgery due to packaging defects that may compromise the sterile barrier. Contact with non-sterile devices could cause infection, sepsis, or ischemia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall for a real packaging defect that compromises sterile barriers in a cardiac surgical device. While potential harms include serious complications like sepsis and ischemia, this is classified as High (not Severe) because it is a risk-of-harm recall without reported injuries documented in the source.
Plain-English summary
Maquet Medical Systems USA is recalling QUADROX-i Adult Oxygenators used during cardiopulmonary bypass procedures. The product packaging may contain small, non-visible pinholes that compromise the sterile barrier.
Affected models include HMO 70000-USA, HMO 71000-USA, and BEQ-HMO 71000-USA (all lots) with nationwide domestic distribution. Exposure to a non-sterile device may result in inflammation, infection, sepsis, or ischemia—serious complications in cardiac surgery patients.
This is an FDA Class II recall.
The recalled product
- Product
- QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829
- Manufacturer
- Maquet Medical Systems USA
- Category
- Medical Device — Cardiac Surgery
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Maquet Medical Systems USA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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